Tremors in PSP land
January 23, 2020
PSPs have become, as the saying goes, part of the wallpaper. Whether high touch or bare bones, PSPs are a must-have component of specialty medicine treatment. To understand how far PSPs have come and may evolve in the future, it’s worth stepping back and revisiting why we have PSPs in the first place.
A couple of decades ago, as specialty drugs began pouring into the marketplace, gaps in the delivery of services came to light: Who would help the patient navigate the reimbursement maze? Who would deliver the medication to its final destination? Who would set up a treatment and lab testing schedule? Recognizing that the existing system couldn’t absorb these new treatment requirements, manufacturers created PSPs to bridge the gaps.1
The jury is in: PSPs work. Not only do they support patients through the logistics of treatment, but—depending on their design—they can help patients achieve better outcomes with their medication. In a study of over 10,000 Canadian PSP participants, those who received motivational phone calls from nurses were 72% less likely to stop treatment.2 The bulk of evidence also suggests that PSPs improve clinical and humanistic outcomes, as well as containing health care use and costs.3
Clearly, PSPs are here to stay. At the same time, the ground they occupy has been shifting. Changes in the specialty drug sector are pushing PSPs into new areas of functionality, and they are being required to adapt little by little. Here are 4 pressure points you need to be aware of, now, in the PSP space.
An expanding specialty drug (and PSP) universe
Every year brings a spate of new and costly specialty medicines to the market, and the future promises more of the same. Specialty medicines accounted for 24% of total drug spend in 2014;4 four years later, the figure had climbed to 32%4 and is set to reach 52% by 2025.5
What specialty changes are we seeing? Biologics are branching out into new therapeutic areas, such as asthma, allergy and stroke.5 The biologic boom extends to biosimilar molecules: As of 2019, Canada approved 17 biosimilars,6 each requiring its own PSP. Sophisticated new cancer treatments, such as immunotherapy and gene therapy, have raised the average annual cost of cancer treatment from $79,000 to $150,000 between 2013 and 2017,4 with no ceiling in sight. With more specialty drugs coming to market, we can expect PSPs to follow suit.
Ethical guideline update
In this climate of relentless growth, it comes as no surprise that PSPs would experience, well, growing pains. Enter the Code of Ethical Practices, created by Innovative Medicines Canada to help the specialty medicine universe stay honest.6 In late 2019, amid media concerns that infusion fees paid to doctors by manufacturers could influence prescribing decisions,8 IMC amended Section 14 of the Code—the section that deals with PSPs. Slated to take effect in July 2020, the updated Section 14 states that “third parties cannot pay or provide a financial benefit to the prescribing HCP in the context of a PSP” except when the physician depends on such payments to ensure access to patients living in remote areas.9
Manufacturers and PSP vendors alike are working to understand the impact of this amendment and tweak their programs accordingly. How remote is remote, for example? What if a manufacturer does not belong to IMC? And the overarching concern: Will PSPs be able to maintain their high value to patients in the wake of the guideline changes?
Squeezed at the margins
In the model that emerged a decade ago, pharmacy and wholesale markups on drugs subsidized the PSP services offered by pharmacy vendors. In recent years, however, reductions and caps on markups have put a strain on the traditional model.
British Columbia’s public drug plan, for example, allows a markup of up to 5% for high-cost drugs—but the limit on certain hepatitis drugs fell from 5% to 2% as of March 2017. 10 In Ontario, the maximum markup for high-cost drugs has held steady at 6% for the past four years, but a recently introduced clawback provision effectively brings the figure down to 5% over a 3-year period. 11 And with a $30 limit on professional fees within public drug programs and a markup reduced down to 2% on about 30 drugs, Manitoba has taken an especially hard-line stand on markups. 12
When you consider that the markups are divided among several players in the supply chain, coupled with tighter margins at the wholesale level, the math no longer works out. Manufacturers require increasingly sophisticated PSP services for their new products, while pharmacies and PSP vendors are expected to provide more with fewer resources—hardly a recipe for sustainability.
A holistic view
Sandra Hanna, CEO of the Neighbourhood Pharmacy Association of Canada, gives a nuanced perspective on drug costs, pharmacy markups and provider sustainability.
“We know the challenges that high-cost drugs pose for payers and the potential strain of pharmacy markups on the system as a whole. At the same time, we need to consider the value pharmacists bring to the mix. As stewards of drug expenditure, pharmacists can increase the use more cost-effective alternatives and ensure patients get the best value from their prescribed medications. A cost-containment strategy that better leverages pharmacists’ holistic knowledge of the drug universe makes more sense than focusing on the small cost slice associated with markups”
Public offering, Quebec style
Here’s a new twist: In September 2019, the Association québecoise de pharmaciens propriétaires (AQPP) announced its intent to deploy a province-wide PSP for the more than 2,0005 owner-pharmacists it represents.13 The effort grew out of perceived inequities in the flow of specialty drug prescriptions to Quebec pharmacists—like the fact that 38% of prescriptions for five top-selling specialty drugs fall into the hands of just five pharmacies.5
Lending regulatory weight to the initiative is 2016’s Bill 92, which states that manufacturers or wholesalers cannot confine the supply of medications to a limited number of pharmacies.13 In effect, the Bill protects patients’ rights to choose their own pharmacy to provide the services they need. If a community pharmacy lacks the infrastructure to provide specialty medicine services, AQPP intends to step in and fill the gap. Other provinces are watching.
These seismic shifts make it clear: PSPs must stretch to survive. For this to happen, stakeholders need to get creative. There are several ways this can happen.
References:
Making sense of Canada’s specialty pharmaceuticals market. 20Sense. https://static1.squarespace.com/static/58fd16af1b631b1afffae9e0/t/5a5667159140b755af315fb2/1515611926071/20Sense_Back_to_Basics-Specialty_Pharmaceuticals_and_PSPs_ENG.pdf
Gerega S et al. Canadian Study of Outcomes in Adalimumab (HUMIRA®) Patients with Support for Adherence – Results from the Companion Study [abstract]. Arthritis Rheumatol 2016; 68 (suppl 10).
Ganguli A et al. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review. Patient Prefer Adherence 2016; 10: 711–725.
Mian N. Presentation at the 2019 CFP Pharmacy Forum, November 2019.
Association québécoise des pharmaciens propriétaires (AQPP). Presentation at the 2019 CFP Pharmacy Forum, November 2019.
Originator biologics and approved biosimilars in Canada (table). 20Sense, November 22, 2019.
Innovative Medicines Canada Code of Ethical Practices. http://innovativemedicines.ca/ethics/code-of-ethics/
Grant K. How a blockbuster drug tells the story of why Canada’s spending on prescriptions is sky high. Globe and Mail, October 20, 2018.
Innovative Medicines Canada Ethics. http://innovativemedicines.ca/ethics/
Markup policies in public drug plans, 2017/18. Patented Medicine Prices Review Board Canada. http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/refdocs/Markup_Policies_2017-18_EN.pdf
Personal communication with Sandra Hanna, CEO, Neighbourhood Pharmacy Association of Canada.
Letter to pharmacy stakeholders. Manitoba health, seniors and active living. July 18, 2017. https://www.pharmacistsmb.ca/files/Professional%20Fee%20Amendments%202017%2007%2018.pdf
PSP Insider, Fall 2019. Matrix Healthcare.