Biosimilar Breakthrough: Alan Low on the Impact of B.C.’s Biosimilar Policies
January 21, 2021
Dr. Alan Low surely needs a separate closet for his numerous hats, which include frontline pharmacist, researcher, advisor, instructor, textbook author, corporate officer and previously hospital practitioner. A Clinical Associate Professor at the University of British Columbia, Alan coordinates and teaches the Pharmacy Practice Management and Leadership course as well as serves as a preceptor for pharmacy students. As Executive Director of Medicines Access Coalition BC (MedAccessBC), he works to improve B.C. residents’ access to life-changing medicines. His deep expertise in biologics has given him the ear of policymakers and health professionals and made him a sought-after consultant and speaker.
Now that biosimilars have become part of the landscape in B.C., can you comment on how they are working for patients?
By and large they’re performing very well and are offering the same clinical benefits as the matching originators, though some patients may have had unexpected responses. Most patients have adapted to biosimilars without any problems or complaints. Occasionally, a patient’s negative beliefs about biosimilars can weaken the perceived response—the so-called nocebo effect. Separating out actual from perceived negative effects can be difficult. It’s important to educate health professionals on how to instill confidence in patients and avert misguided perceptions. Words have power!
Can you tell us about the British Columbia Biosimilars Initiative?
The idea behind the initiative, which was introduced in 2019, is to optimize public resources by switching patients from originator biologics to their biosimilar versions. It saves costs to the system and improves patient access to medications. As a direct result of the program, the B.C. government has been able to add new biologics and other advanced medications to its formulary, as well as covering new laboratory tests such as fecal calprotectin. The actual savings and impact to patients and the health system are yet to be reported.
How have physicians and patients responded to the program?
Most physicians and patients have embraced the program and made a smooth transition in rheumatologic conditions, less so in gastroenterology. A few doctors expressed concerns about the evidence for “non-medical” switches and about the lack of clarity in the special authorization process for staying on the originator biologic. Education and improved communication are helping to iron out these challenges. To prepare patients for the program, I offered education sessions at my pharmacy and gave talks on behalf of various patient groups. In my experience, if a patient has trouble absorbing or accepting the change, continued education can help relieve anxieties and concerns, along with informing them of their options. People do not like to be forced into a treatment.
What role do patient support programs have in biologic treatment in B.C. and in particular with switches to biosimilars?
They’ve been both a help and a hindrance. When a patient is transitioning from an originator to a biosimilar, they have to deal with both the old PSP and the new one, which can cause confusion. PSP coordinators are restricted in what they can say about treatment, so the patient may not get the full picture. Logistics can get especially complicated for patients on infused drugs, who may have to move to a different infusion centre with different care providers. An idea gaining currency is the universal PSP, which would streamline enrolment and make life easier for both physicians and patients.
How are multiple biosimilars being handled at the pharmacy?
The ideal is to have all the biosimilar options in stock, so patients coming in with a prescription can receive the prescribed medication on the spot. Realistically, not all pharmacies can bear the costs of such a model. Even if a pharmacy has limited stock, advance communication between prescriber and pharmacy can facilitate just-in-time dispensing: the pharmacy gets a heads-up on the prescription and can order it while the patient is taking care of enrollment and reimbursement.
What is the pharmacy’s role in choosing which biosimilar molecule is dispensed?
At the moment there is no interchangeability policy for biosimilars. If the prescribing physician selects a particular biosimilar version, prescribed by its trade name, the pharmacist has no authority to switch it to another brand, even though it is the same molecule. On the other hand, if the prescription just states the molecule or chemical name of the biologic, the pharmacist can select which biosimilar version to use, after consulting with the patient. Tools such as PharmaNet and real-time adjudication allow pharmacists to find out which medications the patient has been receiving in addition to which biosimilars are covered and what each copay is, so they can guide patients to choose the most cost-effective or preferred options.
Do you anticipate the interchangeability rules to change at some point?
We need studies proving that the pharmacokinetic properties of the various biosimilars corresponding to a single originator aren’t too far apart, and that clinical efficacy and safety are within defined limits. Once we have this data, I expect that many biosimilars will become interchangeable with the originator biologic and other biosimilars.
Do patients themselves have a say in biosimilar selection?
With brand-name and generic drugs, the current public system covers the lowest-cost alternative, and patients who prefer a more expensive brand-name version have the option of paying the difference. This is not the case with biosimilars right now: patients either agree to the biosimilar covered by the public payer or they pay 100% out of pocket, or some may be able to receive coverage through their private health plan. I hope the future will bring more choice to patients taking biosimilars, perhaps with copays to account for differences in cost where the patient can pay the difference from the biosimilar to the originator biologic if they prefer.
Where do you see the biosimilar conversation going in the next 6 to 12 months in B.C. and the rest of Canada?
Right now, pharmacists can’t make any changes to biologic or biosimilar prescriptions without contacting the prescribing doctor. We have frontline contact with patients, who often tell us about their preferences of self-injectors and syringes, but we can’t act on this knowledge without contacting the prescriber. I think regulations will open up and give more scope for pharmacists to use clinical judgment. I would love to see certification programs for pharmacists in the area of biologic and specialty drugs.
This year, we expect to see multiple biosimilars for adalimumab enter the market. Any thoughts about the complexities this may bring?
More choice is always a good thing for patients. Sometimes the choice comes down to the injector pen, and the competition will likely encourage innovation in this regard. A competitive market also encourages payers to negotiate better prices. There is always a risk of problematic business practices that could put pressure on prescribers, but we have mechanisms, such as oversight from PharmaCare and professional regulatory Colleges, to prevent this from happening.
What advice would you have for manufacturers of biosimilar products?
It would be useful for manufacturers to approach payers and policymakers as a group, to help promote a patient-centred and cooperative paradigm. Collaboration can also help avoid heavy-handed policies that stand in the way of patient care. I encourage manufacturers to not only work with pharmacists, but also involve patient advocacy groups in the push toward fair market solutions. Thanks to my work with MedAccessBC, a group devoted to removing barriers to accessing and receiving medicines, we have seen policy changes as a result patient advocacy, I can attest to the power of such organizations.