Proposed legislation across 23 US states to
force payers to increase reimbursement of abuse deterrent (AD) opioids will
likely face significant resistance due to state cost implications, most experts
said. The state payer Medicaid- and private payers alike will likely argue that
AD opioids do not currently have enough evidence to support the idea that they
prevent abuse and addiction, experts added.
Some products approved with AD labelling
include Teva Pharmaceuticals’ (NYSE:TEVA) Vantrela (hydrocodone bitartrate),
Egalet’s (NASDAQ:EGLT) Arymo (morphine sulphate), Purdue Pharma’s Targiniq ER
(oxycodone and naloxone extended-release tablets) and Pfizer’s (NYSE:PFE)
Embeda (morphine sulfate and naltrexone).
Experts noted action to push any state
legislation that would force access to more expensive AD drugs would directly
impact the Medicaid budget, as Medicaid is one of the largest payers of opioid
products. Thus only a few states at most will implement changes, most experts
said. Private payers and patients would also balk at paying more, including
higher premiums, as a result of insurers being forced to reimburse AD products,
they added.
That said, two other experts were more
optimistic on legislation prospects, considering the continued development of
AD formulations. But others said only further data of benefit of AD opioids
could sway states and payers in favor of increasing access to AD opioids, given
abuse likely stems from diversion rather than misuse by the patients who are
prescribed opioids.
State and payer
costs prohibitive
Based on conversations with consultants, it is
expected that only a few states will implement very strong legislation to force
physicians to prescribe AD opioids, said Nikolaj Sorensen, CEO of Orexo, a
Swedish company which markets opioid products for both pain and opioid
dependence. The extraordinary cost increase of AD opioids compared to cheap
generic formulations is one of the major blocks to passage for most states,
explained Sorensen, with one consultant agreeing. AD opioids can cost as much
as 10 times their generic equivalent counterparts, noted one pain expert.
One of the biggest hurdles to passage is the
costs of AD coverage would be primarily absorbed by Medicaid budgets, with
private health insurance companies also affected, explained Sorensen, the
consultant and Bob Twillman, executive director, Academy of Integrative Pain
Management, Lenexa, Kansas. Medicaid operates annual budgets, so long-term
benefits from AD formulations, assuming they prevent overdose and addiction,
are not helpful, noted Michael Barnes, chairman, The Centre for Lawful Access
and Abuse Deterrence, Washington, DC. Also, there are cost implications to
patients with private health insurance in that premiums would likely rise as a
result of the increased cost to payers, added Sorensen. A patient with good
intentions and who is unlikely to abuse, or misuse opioids will object to
paying higher premiums, so legislation is likely to be unpopular, he noted.
Payers will also object to paying more for a product if a patient is not abusing
it, he explained.
Private health insurance companies are
lobbying against any state legislation, using the argument that AD opioids are
being advertised as safe when they still carry risks, which is a powerful and
valid argument, said Twillman. Their lobbying is pretty persuasive to prevent
legislation passage, he said. However, the legislation is being pushed by AD
pharma makers, he added.
In California there was a bill that attempted
to mandate at least one AD opioid be placed on formularies with no increased
co-pay, however it was rapidly killed, said Jeremy Adler, senior pain
management physician assistant, Pacific Pain Medicine Consultants, Oceanside,
California. States such as New York and New Jersey vetoed potential legislation
in 2016 due to cost and evidence concerns, though new bills may be possible,
said Shruti Kulkarni, policy director, The Centre for Lawful Access and Abuse
Deterrence, Washington, DC and the consultant. However, without a major
political leadership change in New York, New Jersey and California, any new
bills are likely to be vetoed again, noted Barnes.
In New Jersey, the governor that vetoed a bill
to increase access to AD opioids, noted it would cost the state more than USD
11m each year, and there were limited data supporting the usage of AD opioids
to prevent addiction, said the consultant. In Utah, the state Senate requested
a cost/benefit analysis study which concluded that AD drugs should be subject
to higher cost sharing given that limited data demonstrates the value of AD
opioids, said the consultant. The Virginia state Senate has similarly requested
a study on AD opioid coverage which is expected to conclude and provide
recommendations imminently, he added.
Limited data
for AD opioids
Despite other experts noting the difficulty of
legislation passing, Kulkarni said she was more optimistic because the FDA is
strongly encouraging generic manufacturers to make AD formulations which could
have a positive impact on their uptake. Barnes agreed, adding that whilst at the
moment there are only a few products on the market, the approval of more AD
drugs would likely help create further competition and increase access. The AD
market is growing with some recent FDA approvals such as Vantrela and Arymo, he
said. There are also an additional 20-30 AD products in the clinical
development pipeline, he said. One thing that would likely help swing the
pendulum in favor of AD opioid coverage would be outcomes data showing AD
products help reduce overdoses and addiction and thus there may be a better
cost/ benefit ratio, noted four experts.
However, it may be difficult to get data to
demonstrate AD opioids have a significant impact on abuse, as the majority of
opioid abuse is as a result of diversion, said Adler. Physicians can assess
patient records to determine addiction potential and prescribe AD opioids in
those cases, but they cannot prevent medication from being stolen or diverted,
he said.
One pain expert and Twillman noted that
following Purdue’s OxyContin (oxycodone-controlled release) change to an AD
formulation, data shows its abuse dropped significantly.
OxyContin is the only AD opioid with any
real-world data supporting its efficacy in reducing abuse, the pain expert
added. Considering the few AD options on the market, the ability to assess
their effectiveness is limited, he said. Also, nearly all AD products are
long-acting opioids, which account for only 3% of the total prescriptions for
opioids, and most abuse occurs with immediate-release opioids, heroin and
fentanyl, he explained.
Hamish McDougall
Reporter, London
Hamish has a BSc in Neuroscience from the University
of Sussex and is primarily covering the neuroscience indications for BioPharm
Insight. Prior to joining us he was assistant commissioning editor for a
well-known collection of biomedical journals at Expert Reviews, including
Expert Review of Gastroenterology & Hepatology, Expert Review of Clinical
Pharmacology and Expert Review of Respiratory Medicine.
Fiona Barry
Reporter, London
Fiona previously worked in France as a journalist at
William Reed Business Media, covering global manufacturing, regulatory and
outsourcing news for the biopharmaceutical industry. She has also reported on
global food and beverage companies. Fiona holds an M.A. in English and a B.A.
in English and Philosophy from Bristol University. She speaks English and
French.