We
have all seen the trend data. The situation is likely to become more
complicated, not less so, in the coming years. The annual report by CVS
Caremark anticipated that by 2015, specialty drugs will account for 27% of the
prescription spend, and that annual growth in the spend can be as high as 22%
for 2013, matching the figures for the past few years.1 The data
from Express Scripts shows that although the trend for the major traditional
product categories was only 0.1% in 2011, the trend for the specialty
pharmaceutical category (e.g., anti-inflammatories, multiple sclerosis, cancer,
HIV, etc.) was 17.1%.2 Ample evidence now exists that the specialty
pharmacy utilization and cost growth will continue in the healthy double-digit
range, for at least the next few years. It will be fueled not only by the large
number of specialty products in the later stages of clinical development, but
other factors as well, including slowly evolving expertise (and commitment) by
payers to control access to these products.
A few years ago, I worked on an annual publication
sponsored by Bristol-Myers Squibb.3 Similar to other trend reports,
we surveyed payers (including corporate employers) to determine how they were
reacting to several trends in the industry. We asked them about how they
managed specialty pharmaceuticals (in 2008) and what changes they intended to
make in 2009 and beyond. Back in 2008, 40% of those surveyed indicated that
they already shifted any injectable/infused agents from the medical to the
pharmacy benefit, and an additional 16% planned to do so in 2009. At that time,
51% said that by 2008, they had already assigned injectable agents to specialty
pharmacy management and an additional 14% said they would do so in 2009.3
It is clear that many health plans and insurers have turned to pharmacy benefit
management to manage the growth of the specialty pharmacy category. However,
many of these injectable/infusible products would traditionally be part of the
medical, not pharmacy, benefit. In some large plans, drugs covered by the
medical benefit are evaluated by a dedicated technology assessment committee
(or rely on other independent resources, such as private consultants or a
national technology assessment body, like Blue Cross and Blue Shield’s). If
pharmacy coverage decisions are made by the Pharmacy & Therapeutics
(P&T) Committee, does this mean that this body is the de facto tech assessment committee in most plans? This seemed to be
the case in the last decade, particularly when it came to certain devices and
diagnostics.4 Or will technology assessment committees, when
available, decide on pharmacy benefit coverage for these specialty
pharmaceuticals? The move to pharmacy benefit management of specialty products clouds
the discussion considerably.
It would also help if a universal definition of specialty
pharmaceuticals was well accepted, based on cost, distribution, storage, and/or
route of administration. I’m showing my age here, but I clearly recall when the
term specialty pharmaceuticals generally referred to blood products only, which
were almost universally covered through the medical benefit. Fast forward to
the 1999 introduction of TNF inhibitors and then similar other
office-administered and self-injectable products. By 2013, we’ve added oral
agents into the specialty mix.
Today, are payers equipped to determine whether a
specialty medication offers real value (or even a reasonable value
proposition)? And yet another critical question for payers: In light of recent
trends, should the coverage decision making body be removed from the shackles
of pharmacy or medical benefit classifications altogether? This infers that a
merged group of coverage decision makers, with a composition distinct from that
of a traditional P&T Committee or technology assessment committee, may
contribute further to the discussion.
Clearly,
the P&T Committee backbone of pharmacy decision making in managed care is
being tested. In recent years, the need for device (specifically drug-delivery
systems) and diagnostic coverage decisions is weighing it down. A new
evolutionary step may be needed to help payers meet the challenges of specialty
pharmacy products.
(Note: This blog was first published in January 2013 for the Health Payer Council [www.healthpayercouncil.com]).
REFERENCES
1. 2011 Insights:
Changing Rules Changing Roles. Scottsdale ,
AZ
2. 2011 Drug Trend
Report. St. Louis , MO
3. 2009 Biotechnology
Monitor & Survey. Princeton ,
NJ
4. Mehr SR: The evolutionary role of the pharmacy and
therapeutics committee in
technology assessment. Manag
Care Interface 2006;19(1):42-45.
Questions:
1. Does your P&T Committee or Medical Technology
Assessment Committee decide whether to cover specialty pharmaceuticals?
2. If a unique body were assigned to making specialty
pharmacy coverage decisions, how would its composition differ from that of
today’s P&T Committee?
3. What is your greatest challenge (other than the cost
trend) in terms of managing the specialty category?
SM Health Communications provides writing, consulting, and market research services for the long-term care and payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. For more information, please visit www.smhealthcom.com or contact Stanton stan.mehr@smhealthcom.com .
