What are the most important things for patients to know about biosimilars?

For people with inflammatory arthritis like rheumatoid arthritis, or other chronic diseases that benefit from biologic medicines such as Crohn disease, psoriasis, [multiple sclerosis, MS], lupus, and others, biosimilars represent new treatment options simply because they are nearly identical to the originator biologic, but not exactly the same.

However, like with every medication, each patient will respond a little differently. Our advice is that patients with arthritis who are prescribed a biologic or biosimilar, track their response to treatment using our ArthritisPower research registry. Patients can download the free app and use it to enter their symptoms and treatment responses. They can also participate in arthritis research. It’s a great tool to understand how you are actually responding to a medicine (and other therapies) over time. Folks can learn more an download the app at www.ArthritisPower.org.

Videos

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains what patients should know about biosimilar therapies.

Seth Ginsberg: What Patients Need to Know About Biosimilars

Despite challenges from industry groups, a number of states have recently enacted drug pricing regulation. Do you expect to see more states passing such laws?

I think I just read that there were 2 more states that had either proposed or enacted similar legislation to what Maryland passed. This is an outgrowth of the whole concern about drug pricing, so I think it’s something that’s going to continue.

The pharmaceutical companies and the associations I think are going to continue to fight against those, and I think they’re going to do it for a number of reasons. One, a lot of the laws are somewhat vague and make it difficult to determine whether someone is violating the law or not.

The other big issue is, when you’ve got different requirements in different states it makes it very difficult for companies to price their products. I think there’s going to be a big push to try and get some sort of national standard.

We saw this many years ago with clinical trial disclosure requirements. A number of states started enacting laws requiring companies to disclose clinical trial information; I think Maine was the first one. Again, industry was very concerned about having multiple, disparate requirements from state to state, so they pushed for a national requirement, and that was enacted back in 2007. This is one of those issues that I think companies will want to have any national legislation, but I think they are going to fight against having different requirements in different states.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes trends in state legislation on drug pricing and industry reaction to such laws.

Scott Lassman: Drug Pricing Legislation

Can you comment on how the FDA has changed under new leadership by Commissioner Scott Gottlieb, MD?

The FDA is like a big freighter ship: it doesn’t change really quickly. That being said, I actually have seen a number of changes, or what I perceive to be changes, which is that he’s not shying away from some of the most controversial issues. I thought it was telling that Dr. Gottlieb jumped right in and said that FDA has a role in drug pricing. This was something that the FDA has shied away from for years. While Dr. Gottlieb was clear that the FDA does not have a direct role, he did say they have an indirect role, and is trying to take action to actually speed up the approval of generic drugs and biosimilars. I think he actually has been doing that, if you look at some of the recent approvals for very complex generic products (almost, one would say biosimilar-like), that had been sitting at the FDA for a long time, they’re taking action to actually move those products forward and get them in the market. He seems to be—what I would say is the big issue&mdash;he’s not shying away from the controversial issues. He’s stepping right in, and they seem to be taking a lot bolder action and taking it a lot more quickly than I would have expected.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, describes how the FDA has changed under its current leadership.

Scott Lassman: Changes to the FDA Under Scott Gottlieb, MD

Do physicians do a good enough job of educating patients about biosimilars versus biologics?

Since I’m not a doctor—although sometimes I like to joke that I could play one on the Internet&mdash;I cannot speak to their overall education about biosimilars versus biologics. But my impression, based on speaking with many rheumatologists and other doctors, is that they’re taking a wait-and-see approach before prescribing biosimilars.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, reflects on physician efforts to educate patients about biosimilars.

Seth Ginsberg: Educating Patients on Biosimilars

What can the industry learn from the response to Allergan’s recent transfer of patents to a sovereign entity?

I think they could learn 2 things. One, that folks will do just about anything to protect a blockbuster product. I’ve got to say that the lawyers who came up with that should get an award; I thought that was unbelievably creative. I guess the lesson is to expect anything.

The second thing folks can learn is that timing is everything. I thought the timing of this was awful. Drug pricing issues are swirling around, you’ve got Congress looking at it, you’ve got FDA looking at it, and to pull what I think can only be considered a stunt like this, it’s just awful timing for the industry. It might be good for the company that did it, but I think it plays very poorly with the regulators and policy makers.

It reminds me of something that happened probably 20 years ago in the Hatch-Waxman context where you had a similar atmosphere of criticism of the industry and criticism of some of the tactics that companies use to ward of generic competition, and just at that moment 1 big company got a new patent issued, and I think it was at 11:00 at night the day before generics were supposed to be approved, they submitted the patent to FDA and blocked generics for another 30 months. That set off a firestorm and actually prompted FTC to complain and FDA to change their regulations. Ultimately, it prompted Congress to step in and change the statute and address something like that.

I actually saw a lot of similarities between that situation and this situation, and I would not be surprised if you see some sort of legislative response to it.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, responds to Allergan's recent transfer of patents to a soverign entity, and gives 2 takeaways for industry.

Scott Lassman: Industry Takeaways from Allergan's Patent Transfer

Will product sponsors need to take steps to transition their products to biologic status?

That’s another good question, I think it’s going to be FDA edict. FDA actually put out a draft guidance document a couple of years ago where they described how they see the transition process going. It was severely criticized by a number of people, and I think the biggest complaint is that it creates what folks have described as a “regulatory dead zone.” What FDA has said is, for things like insulin, the statute says you can submit an [New Drug Application, NDA,] until I think it’s March 21, 2020. But the FDA said that if you don’t get approved by that date, we will not review it any longer, and you have to pull that application and submit it as a biosimilar.

Companies, when they look at this, say, “Well, the FDA’s typical review is 10 months, so if we’re thinking about submitting an NDA say, 9 months before that date, chances are it’s not going to get approved, and we’ll have to pull it. So why would we even submit it?”

Typically, things go through a couple of review cycles, so it might even be longer than 10 months. Actually, if you look at the most recent insulin and insulin-like products, FDA’s review was anywhere from 2 to 5 years. Then you have to factor in, well, "What if we’re subject to a 30-month-stay?" A rational player would look at that and say, at some point, "It doesn’t make sense for us to submit an NDA because the risk that it’s not going to get approved is too high, so why don’t we just wait and submit the biosimilar application?"

The problem is that you’ve got this 2- or 3- or 4-year period where no one is submitting anything. I think that one is going to be, we’ll have to see, but I think that one is ripe for litigation because FDA’s position from policy point-of-view doesn’t make any sense, and I think legally it’s very suspect as well.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains how the upcoming transition of follow-on biologics to regulation as biosimilars could create a "regulatory dead zone."

Scott Lassman: Follow-on Biologics and the "Regulatory Dead Zone"

How do prior authorizations affect patients who have been prescribed biologics?

Like “fail first,” prior authorization is a tactic used by health insurance providers to reduce prescription drug costs. They serve an important purpose in seeking to reduce healthcare costs; however, when they are excessive in length and difficult to navigate because of variance, and depending on the insurance company requirements, prior authorization can become a real barrier to care.

By requiring physicians to submit additional paperwork to prove that a patient requires an advanced therapy—sometimes still requiring the use of a fax machine&mdash;they are encouraging physicians to prescribe an older, possibly less effective option to avoid the prior authorization effort required by the insurer. Physicians often report having to dedicate several staff members full time to processing prior authorization forms for patients. And from the patient perspective, prior authorization requirements mean that accessing their prescription is delayed, which can lead to serious health consequences or complications, not to mention much more stress.

Legislative efforts to address this issue have focused on streamlining and bringing uniformity to prior authorization forms and appeals processes within states around the country.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses the impact of prior authorization requirements on patients and providers.

Seth Ginsberg: Biologics and Prior Authorization

What are fail-first policies, and how do they affect patients? 

“Fail first” is a term often used to describe a health insurance utilization management strategy called step therapy. Step therapy is a program put into place by a patient’s health insurance provider. It encourages the use of less costly yet effective medications before more costly medications are approved for coverage. In some specific instances, step therapy can be an appropriate way to reduce cost, however when applied to more complex diseases and conditions, it can be unethical, prolong suffering, exacerbate disease, and increase cost.

Most of the time, the problem with step therapy is that it unilaterally applies a one-size fits all policy to individual patients without regard to their specific medical history. A doctor may have prescribed a more expensive, more complex medication—like a biologic&mdash;to her patient for specific reasons. For an insurance company to reject the prescription and require a patient to try something different, first, is problematic, to say the least. For example, in many cases, a patient may have already tried the less expensive medication and either not responded to it or experienced an adverse event. But if they are new to their health insurance plan, that history may be disregarded. This puts the health of the person at risk by delaying and/or preventing effective treatment. State legislatures across the country as well as Congress are addressing this issue by reforming the appeals process to bypass a step therapy procedure or accelerate an appeal. Legislation provides specific criteria with which a physician can use justify an appeal and puts in place response time requirements that insurers must comply with when answering appeal submissions from patients and providers.

Fail-first policies intrude on the patient/physician relationship and lead to:

Unstabilized care and the potential for permanent damage to occur

Forcing patients to sometimes take drugs that are not FDA approved for their condition

Our organization has been a leader in helping people understand fail-first practices, educating policy makers and regulators about fail-first practices, and keeping the public updated on each state’s approach to fail first. The web site for that information is www.FailFirstHurts.org.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains how "fail-first" policies, or step therapy, affect patients. 

Seth Ginsberg: Step Therapy's Effect on Patients

What challenges do patients with inflammatory diseases face in accessing biologic therapies?

There are several challenges that patients with inflammatory diseases, like rheumatoid arthritis or RA, face in accessing biologic therapies.

First, patients respond uniquely to biologics. It is impossible for a rheumatologist to predict which medicine might work best in their patients, based on specific criteria. This is in our future, however. Instead, today, patients must often go through a “trial and error” process when they try a medicine for 3 to 6 months to see if there is a positive response. It could take months or even years for a person with arthritis to find an effective therapy. So the challenge here lies in not knowing which biologic to select for optimal results.

Another challenge patients face isn’t related to biology. Rather, it’s related to their wallet. A person’s health insurance—public, private or a combination&mdash;will often dictate which medicines are available in their plan’s formulary and affordable based on the required co-pay or deductible. Rheumatologists (and their practice staffs) spend countless hours working with their patients to wade through paperwork and jargon to determine which therapies might be obtainable to the patient. In some cases, patients must go through lengthy approval processes (including prior authorization or “fail first” protocols) to qualify to obtain the medicine prescribed by their physician. It’s not an exaggeration to say that the physician-patient relationship is being undermined by insurance companies (and their partner pharmacy benefit managers) who are making medicine decisions based on dollar signs rather than medical judgement.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses the challenges that patients face in accessing biologic medicines. 

Seth Ginsberg: Patient Access to Biologics

What are some drugs that will be transitioned to regulation as biologics in the future?

That’s a good question. I don’t have a list, I think the FDA put out a tentative list. Enoxaparin probably will not because that’s a sugar, and the way the statute was revised is they added the word “protein.” So proteins are now regulated clearly as biologics, and as I said there’s a transition provision, so by 2020, all of these proteins are going to be transitioned.

So it’s really the proteins, I think somatropin is an example of one, insulin is an example of another, enoxaparin I don’t think is because I think that’s more of a sugar molecule, so I don’t think it’s going to necessarily be covered.

It’s mainly the proteins, and then there’s actually a question; there’s been a petition that was filed. There are a number of products called peptides, which are just a little bit smaller than proteins. The FDA’s cut-off I think is 40 amino acids, so you’ve got some of these products that are 38, 39 [amino acids], and there was a petition that was submitted arguing that those ought to be transitioned as well because they’re close enough. It would be interesting to see how that pans out. I think people want it to get transitioned so they can take advantage of this 14 years of exclusivity. But it’s an interesting question and I think folks are going to be fighting that one out in the next couple of years as we get closer to 2020.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains which products currently regulated as drugs will be transitioned to regulation as biologics by 2020.

Interviews