State Mandates for Opioid Use Disorder Drug Formularies

By inergency On Jan 2, 2024

Research Brief

Require insurers (private and public) to include at least two Food and Drug Administration (FDA)-approved medication types for opioid use disorder (OUD) (e.g., methadone and buprenorphine) on the preferred drug list or their drug formularies.

A panel of experts rated how they expect this type of policy to affect four outcomes: OUD treatment engagement, OUD treatment retention, OUD remission, and opioid overdose mortality. Another panel of experts rated the policy on four decisionmaking criteria: acceptability to the public, feasibility of implementation, affordability from a societal perspective, and equitability in health effects.

Policy Recommendations According to Expert Ratings

Oppose	Uncertain	Support
No	No	Yes

Outcome Summaries

OUD Treatment Engagement

Percentage of people meeting the criteria for an OUD diagnosis who receive two or more OUD treatment services (including medication for OUD) within 34 days of initiating treatment.

Effect Rating	Summary of Expert Opinion	Representative Quotations
Beneficial (selected)	Mandating coverage for multiple MOUDs would address important financial and administrative barriers to engaging in OUD treatment, give patients options, and decrease stigma.	“Being able to access a medication of choice without insurance barriers is very important to even starting on treatment”
Little-to-no	Little difference from status quo, so limited impact on treatment utilization outcomes.	“If the mandate is for 2 MOUD[s], there will be no change if they all already cover buprenorphine and oral naltrexone. The difference would be mandating methadone coverage”
Harmful	N/A	N/A

Effect Rating

Summary of Expert Opinion

Representative Quotations

Beneficial

(selected)

Mandating coverage for multiple MOUDs would address important financial and administrative barriers to engaging in OUD treatment, give patients options, and decrease stigma.

“Being able to access a medication of choice without insurance barriers is very important to even starting on treatment”

Little-to-no

Little difference from status quo, so limited impact on treatment utilization outcomes.

“If the mandate is for 2 MOUD[s], there will be no change if they all already cover buprenorphine and oral naltrexone. The difference would be mandating methadone coverage”

Harmful

N/A

OUD Treatment Retention

Percentage of people meeting the criteria for an OUD diagnosis who remain continuously enrolled in OUD treatment services for at least six months.

Effect Rating	Summary of Expert Opinion	Representative Quotations
Beneficial (selected)	Mandated coverage of multiple MOUDs will give patients options to individualize care and reduce patient costs for continued MOUD use, both of which should improve retention.	“The mandates give patients options. Patients will be more engaged and remain in treatment longer if they can take the medication that works best for their needs”
Little-to-no	Positive but insufficient mechanism to impact treatment retention.	“Absent strategies to encourage the adoption and practice of offering these medications to patients, mandating reimbursement for medications alone may not lead to increased utilization”
Harmful	N/A	N/A

Effect Rating

Summary of Expert Opinion

Representative Quotations

Beneficial

(selected)

Mandated coverage of multiple MOUDs will give patients options to individualize care and reduce patient costs for continued MOUD use, both of which should improve retention.

“The mandates give patients options. Patients will be more engaged and remain in treatment longer if they can take the medication that works best for their needs”

Little-to-no

Positive but insufficient mechanism to impact treatment retention.

“Absent strategies to encourage the adoption and practice of offering these medications to patients, mandating reimbursement for medications alone may not lead to increased utilization”

Harmful

N/A

OUD Remission

Percentage of people meeting the criteria for an OUD diagnosis who do not experience OUD symptoms (other than craving/desire/urge for opioid) for at least 12 months.

Effect Rating	Summary of Expert Opinion	Representative Quotations
Beneficial	Facilitating continuous and covered access to preferred MOUDs should translate to increased remission rates.	“Should improve remission rates by increasing likelihood of receiving/obtaining appropriate medication treatment”
Little-to-no (selected)	Positive but insufficient mechanism to impact OUD remission, given the numerous factors that influence patient outcomes.	“Having medication choice plays into patient outcomes but this policy itself is likely far upstream from the outcome”
Harmful	N/A	N/A

Effect Rating

Summary of Expert Opinion

Representative Quotations

Beneficial

Facilitating continuous and covered access to preferred MOUDs should translate to increased remission rates.

“Should improve remission rates by increasing likelihood of receiving/obtaining appropriate medication treatment”

Little-to-no

(selected)

Positive but insufficient mechanism to impact OUD remission, given the numerous factors that influence patient outcomes.

“Having medication choice plays into patient outcomes but this policy itself is likely far upstream from the outcome”

Harmful

N/A

Opioid Overdose Mortality

Per capita rates of fatal overdose related to opioids, including opioid analgesics (e.g., oxycodone), illegal opioids (e.g., heroin), and synthetic opioids (e.g., fentanyl).

Effect Rating	Summary of Expert Opinion	Representative Quotations
Beneficial	Facilitating continuous and covered access to preferred MOUDs should translate to a decrease in overdose mortality.	“By making medications more accessible for people with OUDs, there will be a positive result in preventing overdose deaths. Putting medications on formularies is a necessary first step”
Little-to-no (selected)	Positive impact of policy on overdose mortality would be limited by the number of people eligible for Medicaid and engaging with the health care system, which would reduce the policy’s effect at the population level.	“It could be impactful if it drives more people into treatment—knowing their insurance will pay. But there will still be overdoses among people who are not yet treatment-seeking, or those who accidentally overdose on painkillers or, say, cocaine laced with fentanyl”
Harmful	N/A	N/A

Effect Rating

Summary of Expert Opinion

Representative Quotations

Beneficial

Facilitating continuous and covered access to preferred MOUDs should translate to a decrease in overdose mortality.

“By making medications more accessible for people with OUDs, there will be a positive result in preventing overdose deaths. Putting medications on formularies is a necessary first step”

Little-to-no

(selected)

Positive impact of policy on overdose mortality would be limited by the number of people eligible for Medicaid and engaging with the health care system, which would reduce the policy’s effect at the population level.

“It could be impactful if it drives more people into treatment—knowing their insurance will pay. But there will still be overdoses among people who are not yet treatment-seeking, or those who accidentally overdose on painkillers or, say, cocaine laced with fentanyl”

Harmful

N/A

Implementation Criteria Summaries

Acceptability

The extent to which the policy is acceptable to the general public in the state or community where the policy has been enacted.

Implementation Rating	Summary of Expert Opinion	Representative Quotations
High (selected)	General public is either unlikely to be aware of this policy or will support expanding medication options covered by (and not requiring prior authorization from) insurance.	“Though much of the general public might be unaware of the nuances of drug formularies, most people would probably support insurer policies that expand medication options”
Moderate	Some of the general public hold uninformed and stigmatizing views of MOUDs.	“To the extent the general public knows about this policy, it is likely less acceptable because it requires support [of] at least one agonist MOUD, which [has] been [a] labeled substitution of one drug for another”
Low	N/A	N/A

Implementation Rating

Summary of Expert Opinion

Representative Quotations

High

(selected)

General public is either unlikely to be aware of this policy or will support expanding medication options covered by (and not requiring prior authorization from) insurance.

“Though much of the general public might be unaware of the nuances of drug formularies, most people would probably support insurer policies that expand medication options”

Moderate

Some of the general public hold uninformed and stigmatizing views of MOUDs.

“To the extent the general public knows about this policy, it is likely less acceptable because it requires support [of] at least one agonist MOUD, which [has] been [a] labeled substitution of one drug for another”

Low

N/A

Feasibility

The extent to which it is feasible for a state or community to implement the policy as intended.

Implementation Rating	Summary of Expert Opinion	Representative Quotations
High (selected)	Infrastructure to implement this policy is already in place, and there is precedent from other medical conditions.	“This is done with other drug classes all the time”
Moderate	Depends on availability of MOUD prescribers and ability to stock pharmacies to meet increased demand.	“Feasibility is limited by available providers, especially for buprenorphine and methadone”
Low	Other current regulations limit this policy’s feasibility, particularly for methadone.	“Given federal [regulations], I don’t think we’d want methadone on the drug formulary [because] methadone can’t be dispensed from a pharmacy for OUD treatment (this would be illegal currently). So the two [MOUDs] would need to be buprenorphine and XR naltrexone, and the methadone piece needs to be dealt with separately—through requirement for reimbursement/in network [opioid treatment program] providers”

Implementation Rating

Summary of Expert Opinion

Representative Quotations

High

(selected)

Infrastructure to implement this policy is already in place, and there is precedent from other medical conditions.

“This is done with other drug classes all the time”

Moderate

Depends on availability of MOUD prescribers and ability to stock pharmacies to meet increased demand.

“Feasibility is limited by available providers, especially for buprenorphine and methadone”

Low

Other current regulations limit this policy’s feasibility, particularly for methadone.

“Given federal [regulations], I don’t think we’d want methadone on the drug formulary [because] methadone can’t be dispensed from a pharmacy for OUD treatment (this would be illegal currently). So the two [MOUDs] would need to be buprenorphine and XR naltrexone, and the methadone piece needs to be dealt with separately—through requirement for reimbursement/in network [opioid treatment program] providers”

Affordability

The extent to which the resources (costs) required to implement the policy are affordable from a societal perspective.

Implementation Rating	Summary of Expert Opinion	Representative Quotations
High (selected)	Increased costs for MOUDs (if any) will be offset by long-run societal benefits.	“It depends on your perspective. These medications save lives and increase productivity—multiple costing studies have shown that they are cost saving. However, they cost insurance companies money and thus the insurance companies may need to be incentivized”
Moderate	Depends on the MOUD formulations selected by a state.	“Affordability is dependent on the preferred formulation, e.g., Vivitrol and Sublocade are expensive options but may be preferred because the provider controls administration”
Low	Some MOUD formulations can be expensive, and mandates could negatively impact states’ bargaining power.	“In the pharmacy benefit, it would have to be buprenorphine and injectable extended-release naltrexone. Injectable extended-release naltrexone is quite expensive and there are serious concerns about appropriate use. In addition, coverage mandates typically take away states’ bargaining power for rebates, which can greatly increase costs even without treating a single additional patient”

Implementation Rating

Summary of Expert Opinion

Representative Quotations

High

(selected)

Increased costs for MOUDs (if any) will be offset by long-run societal benefits.

“It depends on your perspective. These medications save lives and increase productivity—multiple costing studies have shown that they are cost saving. However, they cost insurance companies money and thus the insurance companies may need to be incentivized”

Moderate

Depends on the MOUD formulations selected by a state.

“Affordability is dependent on the preferred formulation, e.g., Vivitrol and Sublocade are expensive options but may be preferred because the provider controls administration”

Low

Some MOUD formulations can be expensive, and mandates could negatively impact states’ bargaining power.

“In the pharmacy benefit, it would have to be buprenorphine and injectable extended-release naltrexone. Injectable extended-release naltrexone is quite expensive and there are serious concerns about appropriate use. In addition, coverage mandates typically take away states’ bargaining power for rebates, which can greatly increase costs even without treating a single additional patient”

Equitability

The extent to which the policy is equitable in its impact on health outcomes across populations of people who use opioids.

Implementation Rating	Summary of Expert Opinion	Representative Quotations
High (selected)	Policy should create an equitable floor for MOUD coverage (especially if all MOUDs are included) and inherently target populations experiencing systemic inequities.	“This policy improves the equitability of MOUD availability by ensuring all patients have at least two options for treatment, improving the likelihood any patient may engage in treatment, and consequently improving health outcomes equitably”
Moderate	Depends on which MOUD formulations are included.	“Would rate much higher if the mandate included access to all 3 FDA-approved medications”
Low	Could exacerbate disparities if MOUD options are limited and no plans are in place to increase access to MOUDs on the formulary.	“Depends on which insurance allows which drug. If all Medicaid patients only have naltrexone and methadone allowed—then this is EXTREMELY not equitable”

Implementation Rating

Summary of Expert Opinion

Representative Quotations

High

(selected)

Policy should create an equitable floor for MOUD coverage (especially if all MOUDs are included) and inherently target populations experiencing systemic inequities.

“This policy improves the equitability of MOUD availability by ensuring all patients have at least two options for treatment, improving the likelihood any patient may engage in treatment, and consequently improving health outcomes equitably”

Moderate

Depends on which MOUD formulations are included.

“Would rate much higher if the mandate included access to all 3 FDA-approved medications”

Low

Could exacerbate disparities if MOUD options are limited and no plans are in place to increase access to MOUDs on the formulary.

“Depends on which insurance allows which drug. If all Medicaid patients only have naltrexone and methadone allowed—then this is EXTREMELY not equitable”

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