InnomarLive Summary: Top Trends in Health Policy

Key takeaways from the session included:

Trends in the Private Payers Market

• Plan sponsors in Canada are dealing with a dramatic increase in the number of high cost drugs: 10 years ago drugs that cost over $10,000 a year represented total spending of ~7% or 8%, today they’re trending at ~40% of total drug spending, and are driven by 1% of plan members.
• Trends to manage rising drug plan costs include the use of pharmacoeconomics, data mining, and pharmacogenetics.
• Pharmacoeconomics: In the past, the majority of drugs were automatically added to private drug plans based on Health Canada approval, not based on a pharmacoeconomic assessment. This year marks a change in the marketplace with all of the major carriers eliminating “prescription by law” plans, and pharmacoeconomic assessment will now be the norm.
• Data mining: Using transactional data from their plan members, private payers are creating meta data to mine for predictors of health risks that can be used to identify plan members, and targeting them for interventions with experts to prevent disabilities.
• Pharmacogenetics: Although in its infancy, private payers are looking to pharmacogenomics, DNA testing to determine gene variations that can predict how a person will respond to medications, as a means to end trial-and-error prescribing.
  
  

PMPRB Framework Modernization

• The Patented Medicines Pricing Review Board (PMPRB) Strategic Plan 2015-20181 included a key strategic priority of framework modernization. The PMPRB Guidelines Modernization2 discussion paper was published in June 2016, and the PMPRB Guidelines Scoping Paper3 was published in December 2017. Since then the PMPRB has sought input on the proposed new guidelines through consultations with stakeholders.
• The proposed amendments to the PMPRB regulations include: three new economics-based price regulatory factors (pharmacoeconomic value, size of market, and GDP and GDP per capita); an updated list of countries to use for price comparison; a complaints-based system of oversight for lowest risk patented drugs; and a requirement of information of price adjustments (e.g. rebates, discounts) given to third parties in Canada.
• The potential new PMPRB framework will include consideration of list prices in countries they feel are more balanced and reflective of overall OECD member countries, and will now also have a risk-based approach that considers value and affordability metrics (see price regulatory factors above).
• The basic structure of the new framework consists of five parts: international price reference (list to list); screening to classify new high priority drugs; high risk drugs; medium and low risk drugs; and re-benching.
• New patented medicines that meet the PMPRB high priority criteria will be considered “high risk drugs” and will require an investigation to determine a non-excessive price, leveraging the work from HTA bodies such as CADTH and INESSS.
• The PMPRB will consult on a revised set of proposed guidelines in Spring/Summer 2018, and a new regulatory framework is expected to be in place by January 2019.
  
  

pCPA Update

• The pan-Canadian Pharmaceutical Alliance (pCPA) negotiation timelines from engagement to close have decreased, and as of March 2018, they have closed 183 files with a letter of intent (LOI).
• The pCPA priorities for 2018 include establishing timelines, metrics, and a more formalized approach to prioritization.
• Currently, the pCPA negotiation process is not first-in-first-out, and there is no official approach to prioritization. The pCPA understands the need for a formal process for prioritizing submissions, and there is a goal to work toward a framework.
• Due to new funding from the federal government, the pCPA expects that there will be increased capacity at the organization that will help with the workload and new pCPA initiatives.
  
  

INESSS Update

• The Institut national d’excellence en santé et en services sociaux (INESSS) has optimized some of the drug evaluation processes in response to the 2017-2027 Québec Life Science Strategy and objective to provide faster access to new drugs in Québec.
• One of the Québec Life Science Strategy targets states better coordination of listing recommendations between INESSS with CADTH, including a maximum one month average gap between final recommendations. This target will require an industry effort of simultaneous filing.
• INESSS changes to the drug evaluation process included removal of submission deadlines, adjustments to the operating rules of the Scientific Committee, extended criteria for accepting files before NOC, and opened pre-submission meetings.
• Changes also include amendments to the biosimilar, companion test, and advanced therapies evaluation processes. 

Performance Agreements

• With the increased cost of new medications, limited budgets, and the uncertainty in coverage decision-making (including efficacy or safety, long-term outcomes, cost-effectiveness and budget impact), payers are looking for innovative solutions for drug access when evaluating new drug submissions. Generally, the higher the price, the less apt a payer will be to accept the uncertainty of benefit, and they will negotiate a price discount and/or a finance-outcomes based scheme.
• Outcome-based performance agreements, in particular, can include conditional coverage (coverage with evidence development or conditional treatment continuation), and performance-linked reimbursement (outcomes guarantee or pattern or process of care)
• Performance agreements won’t apply to all products; however, adoption may be facilitated by the new PMPRB guideline changes; a manufacturer’s inability or unwillingness to decrease price and desire to differentiate based on value; and the trend by health technology assessment bodies to limit trial benefit extrapolation.

Mark your calendars for the next InnomarLive Conference in Toronto on October 4th, 2018 where we will explore Healthcare Innovation: Embracing Digital Technology to Improve Patient Care.
Stay tuned for more information on this conference.

^REFERENCES:

1. ^{PMPRB (2015), “PMPRB strategic plan 2015-2018”, December 2015. Patented Medicine Pricing Review Board, Ottawa. Accessed 30 April 2018.}
2. ^{PMPRB (2016), “PMPRB guidelines modernization: discussion paper”, June 2016. Patented Medicine Pricing Review Board, Ottawa. Accessed 30 April 2018.} 
3. ^{PMPRB rel="noopener noreferrer" (2017), “PMPRB guidelines scoping paper”, December 2017. Accessed 30 April 2018.}