The Market Failure that Will Push Doctors to Keep Writing Opioid Prescriptions
There’s a strong non-addictive, opioid-replacing painkiller coming soon, but most patients won't be able to get it. Here's how we can solve the problem.
Over 107,000 Americans die every year from drug overdoses, mostly opioids. Deaths have been rising for decades and have exploded as fentanyl has become the dominant black market opioid.
Studies find that roughly 80% of people who have opioid use disorders (OUD) started with opioids prescribed by doctors and dentists, usually after procedures (1, 2). Finally, there is a strong non-addictive, opioid-replacing painkiller, suzetrigine, that is expected to be FDA approved in the next 9 months. It could permanently reduce opioid addiction rates by a substantial amount, but only if patients can get it, and therein lies the problem.
Painkillers Without Addiction
In many ways, the catastrophe of the Purdue Pharma / FDA / medical embrace of oxycontin and oxycodone fueled the dramatic increase in opioid addiction. The subsequent crackdown on opioid prescribing then drove millions of people who had become addicted to these legal opioids over to the black market, which catalyzed the explosion of fentanyl use and the record overdose deaths that we see today. Meanwhile, many people who need chronic pain treatment have been cut off from medication as prescribing has become stricter.
What’s been missing as this disaster has unfolded are strong non-opioid, non-addictive painkillers that can widely replace opioids for acute and chronic pain. Now, finally, a strong opioid-replacing option is about to arrive.
Suzetrigine is a novel non-opioid, sodium channel painkiller with no addictive potential, from mid-size pharma company Vertex. It has shown positive results in Phase 3 and is being submitted to the FDA for approval by the end of 2024 or early 2025. Suzetrigine is roughly equivalent in pain reduction efficacy to Vicodin (hydrocodone / APAP), which is one of the most commonly prescribed opioids. We recently reviewed the efficacy and promise of suzetrigine in this article. There are other broad non-opioid painkillers in the pipelines of other companies that may arrive over the next few years.
This is great news—can we start removing opioids from medical treatment to prevent patients from developing addictions? Unfortunately, there’s a huge obstacle: like other new medications, insurance providers will not pay for suzetrigine unless a doctor can show that a patient has tried a cheaper generic drug first and it was ineffective. And the cheaper generics for pain are opioids.
Next year, as tens of millions of Americans are getting teeth pulled, having surgeries, and suffering from chronic nerve pain, they will needlessly receive opioid prescriptions while a much safer alternative sits on the shelf waiting for its patent to expire a decade from now. About 3-6% of those patients who are prescribed opioids will become dependent, generating millions of completely avoidable new opioid addictions every year (1, 2, 3). Non-patients will become addicted too, as many opioid addictions begin with prescriptions that were diverted from the original patient to someone else– leftover pills given to friends or discovered in a medicine cabinet.
A Massive Market Failure
This situation is a negative for everyone— patients, caregivers, families, taxpayers, and the public.
First, it’s a failure of cost control. Opioid addictions have tremendous downstream financial costs. Because the vast majority of these financial costs—social service organizations, law enforcement, the drug war, crime, lost productivity from death and disability—do not fall on insurance providers, they are not incentivized to prevent addictions from forming. The opioid epidemic costs the US over $1.5 trillion a year. Finding a way to get suzetrigine to patients affordably would save the public a tremendous amount of money.
Even more importantly, we are all worse off in the status quo: patients and the public will suffer because we keep creating unnecessary addictions, with all of the wrenching consequences. Even Vertex doesn’t benefit much, since suzetrigine adoption will be so limited.
How to Make Suzetrigine Available to Everyone at Generic Prices
When a pharmaceutical company advances a new drug, like suzetrigine, they do economic analyses and sales projections to determine how much they will earn during and after its patent life. These projections are fairly standard across the industry, particularly over shorter time horizons (1-2 years).
In studies, suzetrigine roughly matched the efficacy of hydrocodone + acetaminophen (Vicodin), which means that it is not considered a ‘superior’ option for pain control, giving payers an additional reason not to pay for coverage. Vertex knows that as a second line treatment, usage will be limited. Let’s make a wild guess and say that Vertex expects to earn $100 million from suzetrigine in the US next year as a second-line treatment. That $100 million cost is already being borne by the public— through insurance premiums, taxes for Medicare and Medicaid, etc.
Instead, if the federal government can step in and offer Vertex $120 million in exchange for making suzetrigine available at generic prices, that would be a win for everyone—Vertex would make more money and remain incentivized to develop safer pain treatments and the public would pay only an extra 20% to get the drug to 5X or 10X or 20X as many people. The result is that those patients are safer, addictions are avoided, and huge downstream costs from addiction are saved. Meanwhile, over the next few years, more non-opioid painkillers are expected to become available from other companies and once this arrangement is established, similar deals can be negotiated and renegotiated depending on market conditions.
This should be an obvious public health win. We should not be willing to accept a single day where suzetrigine is FDA approved but is being denied by insurance companies, forcing doctors to prescribe unnecessary opioids.
How do we get this done?
To get a better policy in place, we need to focus on a clean and simple solution– this is not an inherently partisan issue, but it will require champions in Congress to push for it and agency leadership to develop structures for it. When COVID was growing exponentially, Operation Warp Speed (OWS) was launched to rapidly develop and distribute vaccines because there was public and political urgency. Compared to OWS, suzetrigine access is a much less complex policy and logistical challenge and plans could be put in place by the end of this year, around the time that suzetrigine is expected to be approved.
Mechanistically, there’s no single policy approach through which this must be achieved. Our organization, CASPR, may develop a specific policy and legislative proposal in the near-future, but for now here are some directions to consider.
Policy Options
On an annual basis, the federal government, through the Department of Health and Human Services (HHS), could run cost projections on suzetrigine sales, negotiate with Vertex as described above, and make suzetrigine available to everyone as a low-cost first-line option. Ongoing reviews of suzetrigine adoption, efficacy, and competing medications would ensure fair pricing for annual renewals. As part of this process, specific estimates of downstream savings of addictions avoided could also be developed, to demonstrate annual and overall cost efficiency of the program.
HHS could negotiate an arrangement with Vertex to sell the drug at cost, regardless of the payer, and the government then would provide a fixed payment to Vertex of $X per prescription sold, where X is much smaller than what would have been sticker price. This approach would be more responsive to usage but, like the option above, would still require an estimate of total value to Vertex and the public in order to set the value of X at a level that benefits the public while being high enough for Vertex to agree.
Advance purchase agreements: the federal government could pre-buy some number of doses from Vertex at a negotiated price that enables the government to then offer the drug at pricing low enough that payers will cover or be required to cover. Pre-buying would be the cost control mechanism and would also ensure that production scales up quickly. In Operation Warp Speed, HHS pre-bought vaccines and Paxlovid to guarantee supply and access. Other types of advanced market commitments (AMCs) and incentives may also be helpful for encouraging ongoing non-opioid painkiller development. Here’s a great overview of AMCs. The proposed PASTEUR Act, which offers a prize for developing novel antibiotics, is another potential model.
Additional Considerations
To cover program costs, we could adopt a new tax on opioid painkillers (excluding MOUDs) and use these revenues to subsidize the marginal cost of the above efforts. Individual states could also do this– several states already impose taxes and fees on opioids and this could be an approach that simultaneously raises the cost of opioids while lowering the cost of non-opioid painkillers. Alternatively, and extremely appropriately, we could redirect funds from the Purdue opioid settlement to this purpose. Alternatively, we could tax the pharma industry more broadly, which would be highly appropriate considering how little investment the industry makes in addiction therapies. However, because the policy proposed here would be highly cost saving downstream, it may be easier to get a policy in place without introducing complexities and battles over who pays. Anything that causes delays in affordable access means more lives lost. Taxes could be added in version 2.0.
Longer term, HHS policy and supporting legislation could create an ongoing mechanism for arrangements with drug makers for any new opioid-replacing painkiller as it enters the market. This could involve creating a default negotiation structure, similar to the Medicaid Drug Rebate Program (MDRP) that drug makers can opt for, designed to increase their projected revenues modestly while making their medications available as first-line. It would make sense for this effort to originate at HHS with enabling legislation as needed.
For Medicaid specifically, state Medicaid programs may be able to negotiate cheaper prices with Vertex on top of whatever national MDRP pricing is set. State medicaid programs should ensure that their cost analyses include projections of downstream costs of addictions avoided.
In sum, there are a number of plausible pathways here and politicians, agencies, and health care economists will likely have strong opinions about what is ideal. The most crucial element is to pursue a simple solution that can get adopted and implemented quickly and can be re-evaluated and adjusted as we see results.
This should be consensus politics– there is no culture war here, unlike so many other issues related to drug addiction. One Republican and one Democratic Senator who are ready to champion this approach together may be able to get it done. (If any staffers are reading this, it would also be a shining achievement for any legislator’s legacy— the Senator who helped steer the nation off of opioids while giving people the pain relief they need.)
Because the policy can be designed to benefit all parties, it is absolutely achievable in the near-term with the right leadership. It’s also relatively straightforward compared to other addiction and health policy interventions that often have many more moving parts and unpredictable effects.
The Opioid Crisis Deserves the Same Urgency as Other Diseases
Due to the nature of the disease and surrounding stigmas, there is far less patient self-advocacy for opioid addiction than for other major causes of death and disease burden. For any other large-scale disease with a major medical advance at hand, there would be a groundswell of demand for immediate affordable access. We have to be that groundswell. Letting the first opioid-replacing painkiller sit on the shelf will needlessly drive more Americans into addiction and overdose.
By any measure, the opioid crisis is a public health emergency. With over 100,000 people dying every year while families and communities are torn apart, we must act with the urgency that the crisis deserves. That means doing everything we can to make suzetrigine accessible, at scale, on day 1. This can be done in a cost-efficient way, with ongoing efficacy reviews, and at tremendous downstream savings to the public.
Suzetrigine is a glimmer of real, tangible hope in this decades-long nightmare that has worsened even as we have spent more and more on the drug war and on drug treatment. Let’s seize this moment.
Collaborators:
If you are interested in collaborating with us on our suzetrigine efforts, please contact us through our website, CASPR.org. We are particularly interested in partnering with clinicians and researchers in the field of addiction and folks with experience in economic and public health modeling. We are also working with policymakers and are eager to connect with more kindred spirits as we build a coalition.
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I like your article, but in my opinion you are wrongly equating physical dependence and addiction. Any patient taking opiods for weeks or months will without question develop physical dependence. This is true for beta-blockers, SSRIs, and other classes of drugs. From Dr. Nora Volkow who heads up NIDA:
The term “dependence” has traditionally been used to describe “physical dependence,” which refers to the adaptations that result in withdrawal symptoms when drugs, such as alcohol and heroin, are discontinued. Physical dependence is also observed with certain psychoactive medications, such as antidepressants and beta-blockers. However, the adaptations associated with drug withdrawal are distinct from the adaptations that result in addiction, which refers to the loss of control over the intense urges to take the drug even at the expense of adverse consequences.