Abuse-Deterrent Formulations of Opioid Analgesics Face Uphill Battle
Development, Regulatory and Patient Access Challenges Persist
Commitment by biopharma to the development of new abuse-deterrent formulations of opioid pain medications is hampered by unresolved issues of development complexity; cost and willingness of payers to reimburse; and regulatory requirements for extensive, industry-financed postmarketing studies. Less addictive alternatives to existing opioid drugs that effectively address the overdose challenge where it’s particularly lethal – through injecting and inhaling rather than oral formulation abuse – are unlikely to enter widespread use anytime soon.
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The drug industry and patient advocacy groups have been leery about the imposition of price controls or restrictions on reimbursement for drugs that treat orphan diseases. A review of formulary data from the beginning of the century shows that there has been some pushback from payers about these high-priced drugs, but patient access has not been severely hampered to date.
Singling out prescription drugs as the most egregious of the health care cost sinners in spite of their relatively small role raises the question of why the media and peer-reviewed journals pay so much attention to their cost. Analysts and policymakers should avoid a myopic silo mentality and instead adopt a holistic approach that measures the value and budgetary impact of health care services across all sectors.
Zarxio is the first in an expected wave of US biosimilar approvals as blockbuster originator biologics go off patent. Just as market competition for small molecules has proven to be healthy for both generics and brand-name biopharmas, competition for biologics will likely have similar effects.