Jaime Rosenberg

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in 

Since 2012, beneficiaries who purchase brand-name drugs receive a manufacturer discount that goes toward their out-of-pocket (OOP) costs, which allows them to reach the catastrophic coverage phase with lower OOP spending compared with beneficiaries who purchase generic drugs and receive no such discount. The benefit was implemented by the Affordable Care Act, which attempted to close the Medicare Part D coverage gap.

“As a result of this concern, in early 2018 the Bipartisan Budget Act (BBA) modified the Part D benefit to ensure that beneficiaries would not pay more for biosimilars than for their brand-name counterparts,” wrote the researchers. “While this change corrected the misaligned incentives for biosimilars, it did not extend the protection to generic drugs.”

These findings are based on data from the Medicare Formulary Files for the first quarter of 2018. The researchers focused on the prices of 9 brand-name drugs with an approved generic or biosimilar, including:

Crestor and its traditional generic rosuvastatin

Lantus and its traditional generic basaglar

Abilify and its traditional generic aripiprazole

Invega and its traditional generic paliperidone

Copaxone and its specialty generic glaitramer

Nilandron and its specialty generic nilutamide

Gleevec and its specialty generic imatinib

Prior to the BBA, biosimilars and specialty generic drugs required higher OOP costs compared with brand-name drugs. The difference ranged from $591 for imatinib compared with Gleevec to $1949 for Zarxio compared with Neupogen. A year’s worth of biosimilar Inflectra would cost a beneficiary $4097 compared with $2858 for brand-name Remicade.

During the same period, traditional generics carried an average annual OOP savings of $709 compared with brand-name drugs, ranging from $100 for basaglar compared with Lantus to as much as $1219 for aripiprazole compared with Abilify.

Since early this year, the BBA has resulted in a decrease in OOP spending for biosimilars. For example, patients using biosimilar Inflectra will save $1573 in annual OOP spending relative to pre-BBA spending. On the flip side, OOP spending for specialty generics is still increasing in relation to brand-name drugs because the manufacturer discounts on brand-name drugs have increased from 50% to 70% and are now applied to biosimilars but not other generics.

The researchers noted that, to date, guidance from CMS on biosimilar coverage under Part D has not fully addressed variations in the FDA approval processes for biosimilar products. Of the 9 drugs included in the analysis, just Inflectra and Zarxio are currently approved as biosimilars, while basaglar is not considered a biosimilar product under the Part D benefit because it was not approved or licensed under the abbreviated licensure pathway.

“Considering the distinction between biosimilars and generics within the Part D benefit, where the former is now subject to a substantial discount and the latter is not, it will be important to ensure that approval pathways do not create artificial barriers to the adoption of lower-price generic or biosimilar medications,” noted the researchers.

Dusetzina SB, Jazowski S, Cole A, Nguyen J. Sending the wrong price signal: why do some brand-name drugs cost Medicare beneficiaries less than generics? 

. 2019;38(7):1188-1194. doi: 10.1377/hlthaff.2018.05476.

Articles

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.

Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name Drugs

During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.

Based on a comparative analysis, Sandoz’s 

, Zarxio, prevented febrile neutropenia in both a randomized controlled trial and in real-world practice in patients with breast cancer receiving neo-adjuvant therapy.

Nadia Harbeck, MD, PhD, head of the Breast Center at the University of Munich, Germany, presented findings from an analysis comparing efficacy and safety results of biosimilar filgrastim from the randomized controlled PIONEER trial and real-world surveillance from MONITOR-GCSF.

The pivotal phase 3 PIONEER trial compared biosimilar filgrastim to its reference product in primary breast cancer patients receiving Taxotere, Adriamycin, and cyclophosphamide (TAC) chemotherapy. Patients were randomized to receive the biosimilar, its reference, or to alternate between the 2.

MONITOR-GCSF was a prospective, observational, open-label post-marketing surveillance of biosimilar filgrastim in patients with solid/hematological malignancies receiving myelosuppressive chemotherapy. Patients received primary or secondary prophylaxis with biosimilar filgrastim.

Researchers compared data from 217 patients from PIONEER and 466 patients from MONITOR-GCSF.

The incidence of febrile neutropenia (FN) was comparable between the 2 studies, with 5.1% of PIONEER patients experiencing FN in any cycle and 6.2% of MONITOR-GCSF patients experiencing FN.

However, 74.3% of PIONEER patients experienced severe neutropenia, compared to 19.5% of MONITOR-GCSF patients. Similarly, more patients from PIONEER experienced fever (5.6% vs 3.4%). Meanwhile, a greater proportion of MONITOR-GCSF patients experienced infection (15.5% vs 7.9%).

Looking at safety data, the grade of adverse events was generally higher in the PIONEER cohort, including musculoskeletal and connective tissue disorders (261 vs 20), infections and infestations (31 vs 3), skin and subcutaneous tissue disorders (258 vs 5), and general disorders and administration-site conditions (673 vs 7).

Harbeck underscored the fact that different chemotherapies were used in each study, with TAC being known to have a number of chemotherapy-associated side effects. In addition, since MONITOR-GCSF used a real-world data source, it should be assumed that there was some underreporting of adverse events, she noted.

 is the golden standard of care for patients with non-Hodgkin lymphoma [NHL],” said Alessandra Franceschetti, IPSOS Healthcare, as she presented an analysis of treatment approaches for NHL.

As rituximab has several biosimilars approved in the European Union (EU), the analysis determined shifts in prescribing activity by physicians from the branded version of the drug to a biosimilar version for the treatment of NHL and what the clinical drivers were.

The multi-center medical chart study included 97 physicians responsible for prescribing anti-cancer drug treatments who reported online medical charts of patients with NHL. A total of 640 medical charts of patients with NHL from France, Italy, Germany, Spain, and the United Kingdom were analyzed from July 2017 through September 2017.

Among the 640 patients, 77% were reported as treated with a regimen including rituximab. Of those patients, 7% were treated with a rituximab biosimilar, which was largely driven by Germany and the United Kingdom (14% and 13%, respectively). “This is aligned with what we were expecting, because at the time of the analysis, these were the 2 countries where the commercialization of biosimilars of rituximab had started first,” explained Franceschetti.

In the United Kingdom and Germany, the prescribing of rituximab biosimilars among patients recently initiated to their current line of therapy increased as the line of therapy progressed. In the first-line setting, 11% were treated with a rituximab biosimilar. By the third-line setting, 30% were treated with a rituximab biosimilar.

Those being treated with a rituximab biosimilar were more likely to have indolent rather than aggressive NHL (70% vs 52%) and have Follicular Lymphoma as a sub-type of NHL (56% vs 35%).

“This leads us to conclude that physicians who prescribe a rituximab biosimilar seem to adopt a precautionary strategy, initiating the biosimilar in situations where potential side effects would be less debilitating, such as for patients in better overall health or those associated with a better prognosis,” concluded Franceschetti.

, a proposed bevacizumab biosimilar, has similar structure to US-licensed bevacizumab and EU-licensed bevacizumab; nonclinical studies have shown it has similar toxicity, toxicokinetics, and immunogenicity to the EU drug in cynomolgus monkeys; and comparative clinical pharmacologic studies have shown it has similar pharmacokinetics (PK), safety, and immunogenicity to both the EU- and US-licensed drugs in healthy male volunteers, explained Mark A. Socinski, MD, executive medical director, Florida Hospital Cancer Institute.

Now, comparative clinical study results have demonstrated the proposed biosimilar has similar efficacy, safety, PK, and immunogenicity as EU-licensed bevacizumab in patients with non-squamous non—small cell lung cancer (NSCLC).

In the double-blind, multicenter study, 719 patients with advanced non-squamous NSCLC were randomized to receive carboplatin and paclitaxel every 3 weeks in combination with either the EU-licensed bevacizumab or PF-06439535. The primary endpoint was overall response rate (ORR) by week 19 (and confirmed by week 25). Secondary endpoints included safety, duration of response, 1-year progression-free survival (PFS) rate, 1-year survival rate, and immunogenicity.

The researchers observed that the ORR was 45.3% for those treated with PF-06439535 and 44.6% for those treated with the reference. The median PFS was 9 months for PF-06439535 and 7.7 months for the reference, and the overall survival rate was approximately 66% for both cohorts, with a median of approximately 18 months in both groups.

In regard to adverse events, the rate of hypertension was the same in both arms at slightly less than 10%. Rates of all other adverse events—cardiac disorders, bleeding, VTEs, protein urea, ATEs, and health failure&mdash;were not statistically different between the 2 cohorts.

Socinski concluded by asserting the similarity between PF-06439535 and EU-licensed bevacizumab was demonstrated for the primary efficacy endpoint of ORR, and that there were no notable differences in 1-year PFS rate or 1-year OS rate.

“These results confirm similarity demonstrated in earlier analytical, non-clinical, and clinical studies of PF-06439535 and bevacizumab-EU,” he said.

, director of the breast oncology clinical trials program at the University of California at San Francisco and advisory board member of The Center for Biosimilars

 concluded the session with updated results from the HERITAGE trial.

The multicenter, double-blind, randomized, parallel-group, phase 3 study is evaluating the efficacy and safety of 

 (approved in the United States as Ogivri) compared to reference trastuzumab in combination with a taxane as first-line therapy in patients with HER2-positive metastatic breast cancer.

Patients were randomized to trastuzumab-dkst or trastuzumab, combined with taxane, every 2 weeks. After 24 weeks, patients with responding or stable disease received monotherapy. Patients were followed through 48 weeks for PFS and 36 months for OS. The primary endpoint was ORR and secondary endpoints include time to progression, PFS, and OS at week 48, as well as OS at 36 months or after 240 patient deaths.

Of the 230 patients treated with trastuzumab-dkst, 70% achieved an ORR, compared to 64% of the 228 treated with trastuzumab at week 24. The proportion of patients being treated with trastuzumab-dkst or trastuzumab experiencing a serious adverse event (SAE) at week 24 was also similar (38.1% and 36.2%, respectively). The most common SAE was neutropenia.

Through 48 weeks, PFS was 11.1 months for both cohorts. As assessments are currently ongoing, OS will be calculated after the 36 months or 240 deaths.

At week 24, 1.3% of those in the trastuzumab-dkst cohort and 0% of those in the trastuzumab cohort demonstrated a complete response, and 68.3% of the trastuzumab-dkst cohort and 64% of the trastuzumab cohort demonstrated partial response.

Through week 48, SAEs were still comparable across the trastuzmab-dkst and trastuzumab cohorts (39.3% vs 37%).

“In patients with HER2-positive breast cancer, HERITAGE demonstrated that tratuzumab-dkst, when administered in combination with taxane, results in equivalent ORR compared with originator trastuzumab, it is well-tolerated as first-line therapy, and as maintenance monotherapy after combination therapy results in similar PFS at 48 weeks and OS is comparable, but still immature,” Rugo concluded.

New Directions in Oncology Biosimilars

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at 

Currently, 41 states and Puerto Rico have laws addressing biosimilars and interchangeable biosimilars, and 4 states still have bills pending, according to Benjamin. While there are 5 states that do not have biosimilar laws on the books, there is anticipation that 2 of those states will have a bill by 2019.

State legislation on biosimilars first arose in 2013, with 5 states taking the lead in developing and approving bills: Florida, North Dakota, Oregon, Utah, and Virginia. Three of the states—Utah, Oregon, and Virginia&mdash;had sunset provisions on their bills, meaning the bill would expire at the set date unless it was reenacted. All 3 bills would have expired before the first biosimilar was approved and introduced into the market, but they were reenacted by the states. By the time the first biosimilar was approved in 2015, 10 states had enacted biosimilar laws.

Benjamin then gave an overview of state legislative activity over the years. In 2013, the first biosimilar legislation required that the pharmacist notify the prescriber by either phone or fax within a specified period of time if they were going to dispense a biosimilar. There were also labeling requirements and additional record keeping that were not required for any other drug dispensed, according to Benjamin.

In 2014, new laws added provisions that notification could be achieved by adding a note into an electronic health record, so pharmacists would no longer have to phone or fax. In 2015, an entry into a pharmacy benefit manager’s system that was accessible to the prescriber was deemed as achieved notification, and in 2016, notification and labeling requirements arose for dispensing an interchangeable biosimilar. According to Benjamin, no additional provisions were added in 2017 or thus far in 2018.

Benjamin highlighted the fact that states do not use the FDA’s definition of 

. Instead, they refer to language in the Biologics Price Competition and Innovation Act (BPCIA), which references the standards of interchangeability.

State laws have also given interchangeability a 2-part definition: A biological product determined by the FDA to meet the standards of interchangeability set forth in the BPCIA, or a biological product determined by the FDA to be therapeutically equivalent as set forth by the FDA’s Orange Book—despite the fact that the Orange Book addresses small-molecule drugs and not biologics.

Additional state legislative language, which is not uniform, includes the following:

Notice to the patient required prior to dispensing

A timeframe for notice that varies from 24 hours up to 10 days

Additional labeling requirements and record-retention timeframes

Approval by the patient required prior to dispensing

State Board of Pharmacy-maintained information required on a website of FDA-approved interchangeable biosimilars

No increased liability for a pharmacist who selects an equivalent drug product or interchangeable biological product than incurred by dispensing another drug

Benjamin finished up the presentation by outlining issues and challenges with current state legislation:

State laws are not consistent with the BPCIA’s intent, which is to support price competition and innovation in the market, balanced with consumer interests

Generally, there is no authority for pharmacists to substitute an interchangeable for the reference product without the intervention of the healthcare provider

Generally, there is no recognition of the FDA’s Purple Book, which lists licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations

States will probably continue to enact laws that are not consistent with intent of the BPCIA and will likely change the BPCIA definitions and create barriers to dispensing

Patient and prescriber confidence in these FDA-approved products may be hindered by restrictive state laws

“It’s essential that we continue to provide patients, pharmacists, prescribers, and decision makers with educational resources to better inform them of the potential for these drugs to provide increased access to safe and more cost-effective drugs,” concluded Benjamin.

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.

 

AMCP Session Provides a Closer Look at State Legislation on Biosimilars

In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist 

, chair of the American College of Rheumatology (ACR)’s Government Affairs Committee, discussed trends in healthcare payment models.

The session, moderated by Amanda Conschafter, communications director of the Alliance for Patient Access, kicked off with a discussion of the 

, which was created to improve access to medication for underserved patients. In the program, manufacturers are required to sell separately payable, non—pass-through products, like biosimilars, to participating hospitals at a discount. Hospitals qualify for these discounts if they serve high proportions of low-income patients.

However, according to Winegarden, low-income patients aren’t necessarily getting the benefits intended by the program, because the cost savings from these discounted medicines go to hospitals: “It doesn’t matter if an individual patient is uninsured or of low income. All that matters is if you qualify as a disproportionate share hospital. Now, the program has gone to cover one-third of all hospitals. The idea is you can make a lot of money for the hospital if have 340B qualification, you buy the drug cheaper, but then you have an insured patient who purchases the drug, therefore you’re getting the full price on the drug.”

According to Winegarden, the program needs to be retooled to better serve low-income patients rather than institutions. “We just need the program to get working so that it actually benefits those individuals.”

Of particular concern to Worthing and the ACR are waivers that would allow individual states to restrict the level of care provided to patients under Medicaid. In the case of Massachusetts, said Worthing, “What was proposed and accepted is that Medicaid formularies would be closed down and restricted to allow for more drug competition, so if there’s multiple drugs in one drug class, that the formulary could be written for just one drug to be available for Medicaid patients in Massachusetts, and it would probably be the cheapest or least expensive drug.”

The waiver could have the potential benefit of ensuring that, in classes of drugs with only one available medication, the drug would likely have to remain on the formulary regardless of how expensive it is.

“Everything else I think would pretty much be bad news for the patients,” he said, especially for patients who are currently stable on biologic drugs. If a patient’s therapy isn’t the product that remains on the formulary, they could lose access to their treatment. “In our case with rheumatoid arthritis, or psoriatic arthritis and autoimmune diseases in the joints, that person’s at risk for flaring if they stop their medication.”

Also of concern for Worthing is a proposal to move medications currently provided by the Medicare Part B program into coverage through the Part D program. Worthing says that such a change could cause delays in patient access to drugs because of Part D utilization management; patients may be required to undergo 

. “These things generally mean that there’s a delay of a couple of weeks, or a month, on average, for people getting their drug. So, there’s a delay that we’re talking about adding in to Part B that isn’t there right now,” said Worthing.

Furthermore, patients could incur greater out-of-pocket costs, because the Part B system allows Medicare beneficiaries to acquire secondary insurance to help pay for their share of costs. “Part D doesn’t have that, and there’s a coverage gap. So, not only are these drugs potentially going to be delayed, but they’ll also be more expensive.”

Feldman agreed, saying that, “Part of the reason we have so many patients taking biologics through Part B is because they cannot afford it in Part D. So, this would be really and news to switch these patients form Part B to Part D, and some of these utilization management tools [exist] because there are pharmacy benefit managers [PBMs] involved in Part D.”

Feldman took PBMs to task for rebating practices that have effectively kept cost-saving biosimilars from competing in the marketplace.

“When I testified before the FDA on one of the biosimilars,” said Feldman, “I said we can fast track the biosimilars all we want. We can get them out there and get them approved, but not one person in this country will take it, unless it’s covered under their insurance. As cheaply as we can make them and distribute them, no one is going to take it.” In a marketplace where PBMs structure formularies around the highest 

, she said, the system incentivizes high list prices for drugs.

Winegarden agreed, saying that, “No one has an incentive to have a lower price, and then we wonder why we have higher prices,” and that’s bad news for patients. “Even though the system is finding some sort of efficiency, patients when they go to the drug counter are footing that bill,” he said.

In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.

Panelists Grapple With Healthcare Payment Models and Patient Access

A panel of health experts discussed the pathway and speed of biosimilar development, as well as the barriers to major uptake of these drugs, during a discussion at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17.

Steve Grossman, JD, president of HPS Group, began by dispelling the myth that there can be a comparison drawn between the current generics landscape and the biosimilar approval pathway.

“Leaving aside all the pharmacological differences and the complexity differences between a generic and a biosimilar, it’s just a completely false comparison,” said Grossman. To have an accurate comparison, one would have to look at the generics field in the 1990s, 7 years post-approval, when patients couldn’t simply take any generic in place of an originator product.

“This is one of the handful of times in 60 years that the FDA has a whole new regulatory pathway, and I think they’ve done a good job,” explained Grossman. “I don’t agree with everything they’ve decided, but I think they’ve worked reasonably fast under the circumstances, and I see most of the barriers being things like patient and insurance issues, which [FDA Commissioner] 

 went after. The FDA component is pretty much on schedule, in my opinion.”

While biosimilars have the potential to increase access and save on costs, Allen Meadows, MD, clinical instructor of internal medicine and clinical instructor of allergy at Alabama College of Osteopathic Medicine, and a community-based practitioner at the Alabama Allergy and Asthma Clinic, warned that, with biologics over the years, insurance companies have been making the choice of which brand will get coverage. This practice has led to consequences for some patients, who have had allergic reactions, but the insurance company will force them to use that certain brand anyway.

“I think the key, when we begin to get biosimilars out there, is that there needs to be physician choice,” said Meadows. “A choice that the physician can make in consultation with the patient, so if there’s a 20% risk that this drug won’t work as well or will cause an adverse event, the physician can discuss that with the patient and have a shared decision-making process.”

Grossman agreed, noting that, in approximately 10 years, when the market has matured, physicians will feel more comfortable with substitution. But, said Grossman, we are still in the early stages of the market.

Janet Marchibroda, MBA, director of health innovation at Bipartisan Policy Center, underscored the importance of 

. She highlighted a survey that found that 40% of biologics prescribers believe that biosimilars are not as safe and effective as their reference biologics, a belief that is a significant hurdle for uptake. Equally concerning, many patients fear biosimilars won’t work as well.

Marchibroda also brought up the legal battles, pointing out that 6 of the 9 approved biosimilars in the United States are delayed from going to market because of ongoing legal disputes with the reference biologic’s sponsor.

According to Meadows, some of the issues with biosimilars are that the price points are not dramatically different from those of the branded drugs. Grossman added that, until we have about 3 biosimilars for a reference product, the US market won’t see the competition needed to drive down prices.

“Once we get competition, which could be a while, and once we get the payment incentives worked out, we still have this other problem that people think that the generic model that’s 60% savings is what we need to get to,” said Grossman. “Why can’t it be 20% of a large number? There’s a lot more to be saved on 20% of a big-time biologic than there is on an 80% discount on a dollar-a-day pill.”

According to Marchibroda, typically those in health policy typically consider the 60% to 90% 

 for generics and compare those percentages to 10% to 20% discounts for biosimilars, making it an issue of perception rather than real savings.

Expert Panel Discusses Challenges With Biosimilar Uptake

Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said 

, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17.

Christl kicked off the discussion by taking a look at where the biosimilar industry is 8 years after the implementation of the Biologics Price Competition and Innovation Act. She noted that the United States had preconceived notions of how biosimilar approval and uptake would proceed based on how the biosimilar approval process was going 

“We came in to having this approval pathway later than other areas of the world, and the expectation was that we would have companies bring to us the products that they had approved in other areas and would just seek approval here,” explained Christl. “But, we didn’t see that. What we saw was the global development programs were ongoing, and they were bringing monoclonal antibodies.”

Christl pointed to Europe, where the bulk of initial biosimilar approvals were for therapeutic protein products, such as filgrastim. While the United States’ first approved biosimilar was a filgrastim, the approvals that followed were for monoclonal antibodies, which Christl described as a “much more complex biologic space.”

However, currently, the United States is seeing the same applications that Europe is seeing, the US approval pathway is well established, and there exists a robust pipeline in regard to the applications being submitted for approval, said Christl.

Brian Kennedy, executive director for Alliance for Patient Access, pointed out that there is a natural hesitancy the United States concerning biosimilars, and Christl agreed, noting the need for both provider and patient outreach and the responsibility of the FDA to not merely approve safe and effective products, but also to explain the standards for approval and instill confidence in the pathway program.

The longevity the European Union’s biosimilar approval pathway also translates into different attitudes toward biosimilars in Europe, not just from a regulatory standpoint, but also from a prescribing and community standpoint, said Christl. There have been studies from government agencies on switching from a reference product to a biosimilar, patients are familiar with the data, and they’ve had more 

“It’s not just enough to say, ‘trust us, we got this, it’s different, and you don’t need to understand why,’” said Christl. “It’s really important to explain what we’re doing, how we’re doing it, and what we’re looking for in our scientific standards. That then gives people the information to understand the underpinnings of the approval of those products and have confidence that they will be safe and effective products.”

Initially, the FDA focused its outreach on health providers, particularly prescribers, developing fact sheets to answer the common questions that they received and that prescribers may still seek clarification on. In turn, the agency hopes that the providers and organizations will take and modify the fact sheets for use in communicating with patients.

Christl ended the talk by offering an update on the FDA’s draft guidance on interchangeability: she explained that the agency has a commitment to issue either a revised draft or final guidance for demonstrating 

 no more than 2 years after the comment period closed. As the comment period closed in May 2017, the FDA has until May 2019, but understanding the importance of this guidance, the agency is trying to expedite the process.

Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17.
 

FDA's Leah Christl Provides an Agency Perspective on the Biosimilars Landscape 

During a panel session at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, panelists discussed key barriers to accessing biologics and other innovative treatments, as well as how patient advocacy can be leveraged to chip away at those barriers.

Derek Flowers, coalition manager, Alliance for Patient Access, highlighted 3 common barriers to access: prior authorization, step therapy, and nonmedical switching.

Intended to be a method to stop unnecessary use of costly drugs, prior authorization requires a physician to go through a lengthy process to get a health plan to agree to cover a medication, even if the doctor knows which treatment the patient needs. Due to the lengthy process, the patient’s health could continue to deteriorate, and new symptoms may emerge.

“Not only is it a patient problem, it’s also a problem for physicians and their practices, taking time away from actually treating their patients and spending more time on this administrative work,” said Flowers.

When a patient gets diagnosed with a new condition, and the physician knows what they need to do put the condition under control, a plan may still require the patient to try multiple cheaper medications before they can use the medication the doctor recommends.

Born with a hereditary congenital heart defect, Donnette Smith, president and founder of Mended Hearts, has undergone 5 open heart surgeries, has been treated with stents, and has struggled with high cholesterol. After trying numerous statins, Smith’s cardiologist prescribed her a PCSK9 inhibitor, but Smith’s insurance denied coverage. Smith and her cardiologist went through an appeals process for 2 years, until 2017, when Smith learned that Blue Cross Blue Shield was covering PCSK9 inhibitors for patients with cardiovascular disease.

Still, Smith was denied by her insurance company, and was told she had to go through step therapy again before they would approve the inhibitor. After finally getting approval to initiate treatment in January 2018, Smith’s low-density lipoprotein (LDL) count went down from 282 to 70. Recently, she got notice from her insurance company that they will no longer cover the drug and she will have to go through preauthorization again.

“It’s not just me. There are hundreds of thousands out there just like me,” said Smith. “I run into them all the time and they tell me, ‘I’m just going to give up.’”

Flowers described nonmedical switching as a follow-on to step therapy: once the trial and error process has taken place and the patient has access to the identified treatment, the health plan sometimes finds a cheaper medication used to treat the same condition.

Jeff Hitchcock, president and founder of Children With Diabetes, discussed how nonmedical switching is often used for different insulin products. “While they’re similar, they’re not equivalent,” said Hitchcock. “They’re different molecules, and the companies make them slightly differently. For most people, they might be interchangeable, but they are not for everyone. We’ve been hearing for years about families experiencing forced nonmedical switching by their insurance company from one insulin to another.”

The impact is not just clinical and metabolic, but also financial, said Hitchcock. In addition to experiencing higher copays, there are sometimes hidden financial impacts. Hitchcock gave the example of his daughter, whose plan switched her from one insulin to another without informing her. With her original medication, she was able to use her infusion sets for up to 72 hours, but on the new medication, the infusion sets lasted for about 36 hours, causing her to spend double on insulin sets.

All panelists agreed that a patient’s voice does not go unheard. “When we elevate the patient voice, whether it be a physician’s or whether it be a youth ambassador’s, we always have a higher chance of success,” said Patrick Stone, MD, of the National Psoriasis Foundation.

Flowers emphasized advocacy at the state level, where a lot can get done in a short time. He urged advocates to tell their stories and let their lawmakers know that these barriers do affect people in the state. When advocates see others being successful in other states, it gives them the motivation and power to speak up and share their stories and be confident in what they’re saying, said Flowers.

“The importance of sharing your story cannot be underestimated,” concluded Stone.