Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
By Bill Melville, Decision Resources Group
With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.
The pharmaceutical world is pivoting to address the addictive properties of widely prescribed opioid analgesics. By 2014, U.S. opioid prescriptions exceeded 240 million — one for every American adult. Rates of overdose related to prescription pain relief drugs also increased, reaching 18,893 overdoses in the same year.1 High-profile deaths of celebrities such as Prince, who overdosed on fentanyl in April 2016, have intensified the public and political clamor to reduce addiction and deaths related to opioid analgesics.
Government Initiatives
U.S. regulatory agencies, including the Department of Health and Human Services (HHS), have pushed for greater controls. While the guidelines are not mandatory, most providers are willing to make the changes, according to Decision Resources Group research that surveyed 143 physicians and 41 managed care organization (MCO) pharmacy and medical directors in April 2016. More than two-thirds of surveyed U.S. physicians indicated that they have reduced their prescribing of opioid analgesics — especially immediate release, long-acting, and combination opioid analgesics — due to concerns over potential repercussions.2
Physicians have already been facing great scrutiny regarding opioid analgesic prescriptions. With most opioid analgesics classified as Schedule II (high risk for addiction, accepted medical use with restrictions), MCOs typically require prior authorization and institute quantity limits.
State-level initiatives are moving the needle. Some states have expanded prescription drug monitoring programs (PDMPs) or will expand with federal funds awarded to combat the epidemic. Forty-nine states have some form of PDMP in place, although not all require every prescriber to submit data.
HHS supports the state efforts and approved in late August of this year $55 million in state funding for addiction awareness and drug monitoring programs. However, that is unlikely to do more than chip away at the problem. Congress authorized $181 million in July, but that money has not yet been appropriated and greater funding for opioid crisis intervention will almost certainly have to wait until the next administration.
To tackle the issue among the Medicaid population, some states implemented disease management programs for chronic pain. In the first year of Colorado Medicaid’s program, which began in May 2015, 84 primary-care physicians and pain specialists connected via telehealth to better manage Medicaid members with chronic pain, monitor for signs of addiction, and craft best practices. For 2016, Colorado Medicaid expanded the telehealth program to include specialists licensed to prescribe buprenorphine combinations.
A critical change could come from the federal government placing less weight on a Medicare Advantage star rating measure that rates hospitals’ performance in controlling the pain of its patients. Under the Center for Medicare & Medicaid Services’ (CMS) proposal, it will still assess hospitals’ performance on the measure but would not tie that performance to bonus payments for MCOs, based on concern that it will drive up opioid use. In fact, our survey of MCOS and physicians found that pain prescriptions increased as a result of pain assessments.
While most physicians we surveyed reported that Medicare Advantage plans that offer incentives for star rating measures have not impacted prescribing, more than 40% of specialists we surveyed indicate the new CDC guidelines will increase prescription of non-opioid analgesics, including NSAIDs, local anesthetics and, antidepressants.
In March 2016, the Centers for Disease Control and Prevention (CDC) issued nonbinding guidelines encouraging physicians to prioritize nonpharmacological and non-opioid therapies, using opioid analgesics as a second-line therapy. Many physicians follow this pattern, starting patients with NSAIDs, usually aspirin, ibuprofen, or naproxen. Along with prescribing low dosages of opioid analgesics, the guidance urges physicians to keep drug quantity low — three to seven days’ worth — to decrease the risk of addiction.
Such short-term prescriptions are somewhat atypical in other therapeutic classes but are more common in pain due to the risks associated with opioid analgesics.
Private Payer Programs
MCOs are not standing pat with opioid analgesic management. Most insurers have offered opioid and pain management programs for years, but the continued opioid crisis has pushed several national insurers to take more aggressive approaches. In May 2016, Cigna announced plans to cut opioid analgesic prescriptions by 25% in the next three years, encouraging providers to adopt CDC guidelines and mandating that any opioid analgesic prescription running more than 21 days be checked against PDMPs.
Others instituted programs are targeting different parts of the healthcare spectrum. Anthem’s Pharmacy Home program focuses on ensuring opioid-treated patients use a single pharmacy, rather than allowing them to have prescriptions filled at multiple pharmacies — a common tactic used by addicts. Using its claims data, Aetna contacts physicians in the top 1 percent for opioid prescriptions — so-called “super prescribers” — who often have higher refill rates for opioid analgesics. (Oncologists and pain specialists are exempt.)
With many low-cost opioid analgesics — including generic equivalents — available, most emerging pain therapies will have trouble penetrating the market. For preferred formulary status, the insurers we surveyed typically want new agents priced at a significant discount to the market’s standard-bearer, OxyContin. The effectiveness and low-cost of agents like OxyContin and its generic equivalents have blunted impact from most new agents in the market. Drugs like Belbuca and Butrans are rarely covered on a preferred tier of our surveyed MCOs’ commercial plans; 78 percent of pain specialists we surveyed indicate that restrictions on Belbuca impede their prescribing of this drug.
The pressure to avoid potential abuse and risk of overdose has amplified as the U.S. opioid crisis has grown. Physicians’ sensitivity to this situation is reflected in our findings, in which both primary care providers (PCPs) and pain specialists we surveyed would favor abuse-deterrent opioid analgesics over other branded agents, if placed on a preferred formulary tier.
Opportunities for Pharmaceutical Manufacturers
An emerging agent with potential appeal is tanezumab, a monoclonal antibody developed by Pfizer and Eli Lilly that blocks nerve growth factor (NGF) for the treatment of chronic pain. Progress on NGF modulators as pain treatments has been slow. Clinical trials for tanezumab and all other anti-NGF monoclonal antibodies were put on hold by FDA in 2010, based on concerns that they could worsen osteoarthritis in a small percentage of patients. However, the FDA lifted the hold in 2015, and clinical development has resumed. Eli Lilly and Pfizer plan to seek approval for tanezumab by 2018.3
If tanezumab and similar drugs eventually reach the market, their non-opioid status and new method of treatment could be attractive to MCOs; most of those we surveyed would consider covering tanezumab on a nonspecialty formulary tier if priced at a 100 percent premium to OxyContin.
Despite the difficulties and slow development, the market would jump at drug therapies that treat chronic pain as effectively as opioid analgesics without the potential for abuse. With avenues for reaching the market open again, this could be an opportune time for pharma companies to explore NGF modulators.
For pharma manufacturers with newer and under-development chronic pain drugs, the opportunities for inroads with opioid analgesic prescribers will not soon dry up. Pain specialists will continue to have more latitude than primary care providers to prescribe therapies for patients who do not respond to early-line therapies, while PCPs will still prescribe opioid analgesics when appropriate. Until new therapies demonstrate effectiveness without significant side effects or risk of abuse, more providers will recommend OTC pain drugs and prescribe non-opioid analgesics, or try to adhere to the strict quantity limits imposed on opioid analgesics.
References:
- http://www.cdc.gov/nchs/nvss/deaths.htm
- https://decisionresourcesgroup.com/report/5682/
- http://www.reuters.com/article/us-eli-lilly-pfizer-pain-idUSKCN0YF2VJ
About the Author:
Bill Melville is a principal analyst for Market Access Insights for Decision Resources Group. He works on the Market Overview and Health Plan Analysis product lines and is Managed Markets Insights’ national expert on health exchanges and Medicare. He has been with DRG since 2007. Previously, Melville was a newspaper reporter, editor, and commentary editor in Columbus, Ohio. He holds a bachelor’s degree from Mercyhurst College in Erie, PA.
Image credit: Pain by NY - http://nyphotographic.com/. Licensed under CC BY-SA 3.0 NY via The Blue Diamond Gallery.