Discordance Between Insurance Coverage of Antiviral Medications and Nicotine Replacement Therapy among Individuals with HIV who Smoke

Abstract

Introduction:

Tobacco contributes to the leading causes of morbidity and mortality among persons with HIV (PWH). Yet, medications for tobaccos use disorder (MTUD) are widely underutilized, particularly among PWH. We sought to characterize the extent to which insurance barriers impacted access to MTUD and in comparison, to access to antiretroviral therapy (ART).

Methods:

This is a secondary analysis of data on individuals enrolled in a randomized clinical trial to address tobacco use involving nicotine replacement therapy, and for some, additionally varenicline or bupropion. Medication prescriptions are transmitted electronically from the clinic to neighborhood pharmacies. Data sources included participant assessments and intervention visit tracking forms.

Results:

Of 93 participants enrolled from September 2020-July 2021, 20 (22%) were unable to fill or had difficulty filling their nicotine replacement therapy (NRT) prescriptions because of insurance barriers. These fell into two broad categories: enrollment in a publicly insured managed care plan in which the pharmacy benefit manager excluded nonprescription NRT, or lack of understanding by the pharmacy of the scope of coverage. Of these 20 participants, 5 (25%) were unable to obtain medications at all, and three of these participants dropped out of the study. One additional participant paid out-of-pocket to obtain NRT. No participant was denied coverage of ART, bupropion, or varenicline.

Conclusion:

Gaps in insurance coverage may result in PWH receiving ART without simultaneous medical management of their tobacco use. This may undermine the efficacy of antivirals. Mandated insurance coverage of nonprescription NRT may improve the health of PWH who smoke.

Introduction

The treatment of tobacco use disorder (TUD) in persons with HIV (PWH) infection is essential. Ongoing smoking in PWH is associated with decreased adherence to antiretroviral therapy (ART),¹ and accelerated rates of cardiopulmonary disease.²

The Affordable Care Act of 2010 mandated coverage by Medicaid of medications for tobacco use disorder (MTUD). The potential impact was substantial, given that individuals who smoke are disproportionately insured by Medicaid.³

However, because Medicaid benefits are determined by states that enroll many Medicaid recipients in managed care plans with pharmacopoeias managed by pharmacy benefit managers (PBMs), the actual availability and affordability of these medications varies.

A survey of AIDS Drug Assistance Programs (ADAPs) in 53 states and territories⁴ found that four (8%) provided coverage for all FDA-approved MTUD; 25 (47%) provided partial coverage, while 24 (45%) provided no coverage. Of note, only 9% of ADAPs covered nicotine replacement therapy (NRT).

Five forms of NRT are FDA-approved, of which three—patch, gum, and lozenge—are available without prescription. Many PBMs do not cover their cost, forcing individuals in these plans to pay out-of-pocket. Paradoxically, Medicaid is more likely to pay for antiretroviral therapies (ARTs) without patient cost-sharing than for the cheaper MTUD. In this report we present a series of patients seen at HIV clinics in two states who enrolled in an ongoing trial to address tobacco use, all of whom had difficulty filling prescriptions for MTUD.

Methods

Overview.

We present a secondary analysis from an ongoing randomized clinical trial of TUD treatment in individuals with HIV infection who smoke.⁵ Participants are being recruited from HIV clinics in two states. Accrual began in 2020.

Participants.

Participants are at least 18 years of age. The study is approved by the Institutional Review Board of Mount Sinai Medical Center (NCT04490057). The current analysis reports experiences with the first 93 participants.

Procedures.

The trial uses the Sequential Multiple Assignment Randomized Trial (SMART) design, in which participants are first randomized to a course of NRT consisting of patches and gum or lozenge, or NRT plus contingency management (CM). At 12 weeks, individuals with treatment response continue the same treatment; individuals without response are re-randomized to alternatives, which may include NRT, varenicline, bupropion, and CM. The primary endpoint is tobacco reduction measured at 24 weeks.

Participants in this pragmatic trial⁴ are given prescriptions to fill them at a local pharmacy, as is consistent with usual care.

Data sources.

Assessments occur at baseline and weeks 12 and 24. To monitor intervention fidelity, study staff call coordinators and pharmacists regularly. Pharmacists track participant experiences with MTUD. Concerns raised during supervision calls prompted the current report. Some participants had been unable to fill their prescriptions on the initial pharmacy visit because of coverage exclusions by their plans’ PBMs of nonprescription NRT. These were generally individuals insured by Medicaid managed care plans. We defined difficulty filling a prescription as a decision by the pharmacist not to fill a participant’s prescribed MTUD.

Results

The study began in September 2020. Of the 93 initial enrollees, 20 (22%) were unable to fill their NRT prescriptions on the initial pharmacy visit. Table 1 describes clinical characteristics of these participants. Twelve of the 20 (60%) are female, median age 56 years. Every participant is Black and/or Hispanic/Latino. Of all participants, 8 (40%) were insured by Medicaid, 8 (40%) by Medicare, 2 (10%) by private insurance, and 6 (30%) unknown. (Percentages exceed 100% because some participants had both Medicaid and Medicare.) At least 5 (25%) of the publicly insured participants were in managed care programs. All participants were taking at least one antiviral agent.

Table 1.

Characteristics of SMARTTT Trial Participants Unable to Access Nicotine Replacement Therapy (NRT).

Participant	Smoking medications	HIV medications	Insurance	Medications for tobacco use disorder resolution
1	Patch 21 mg Lozenge 4mg	Elvitegravir/cobicistat/emtricitabine/ tenofivir alafenamide	Medicaid	Did not cover medications. Participant paid out of pocket.
2	Lozenge 4 mg	Bictegravir/emtricitabine/tenofovir alafenamide	Medicare, Medicaid	Did not cover medications. Participant paid out of pocket for nicotine lozenges.
3	Patch 21 mg Lozenge 4mg	Abacavir/dolutegravir/lamivudine	Medicare, Medicaid	Medications initially not covered; then covered after phone call to retail pharmacist from study team.
4	Never picked up Patch 4mg, Gum 4mg	Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide	Medicaid	Medications not covered. Participant dropped out of study.
5	Patch declined, picked up inhaler	Emtricitabine/rilpivirine/tenofovir alafenamide	Private insurance	Medications not covered. Participant dropped out of study.
6	Patch 21mg Gum 4mg	Abacavir/dolutegravir/lamivudine	Medicare, Medicaid	Medications not covered. Participant received some free medication, then dropped out of study.
7	Gum and patch	Emtricitabine/tenofovir/darunavir	Medicare, Medicaid	Medications not covered. Two weeks of nicotine patches obtained from state smokers’ quitline after referral by study personnel. Nicotine gum was not available. OTC card didn’t work. Eventually obtained gum from pharmacy.
8	Lozenge and patch	Bictegravir/emtricitabine/tenofovir alafenamide	Medicaid	Difficulty obtaining NRT from independent pharmacy. Phone call from study physician obtained NRT for participant.
9	Lozenge and patch	Elvitegravir/cobicistat/emtricitabine/ tenofovir	Medicaid	Difficulty obtaining nicotine patch, not lozenge. Participant told her insurance does not cover patch. Phone calls to pharmacy from study physician and staff obtained patches.
10	Lozenge and patch	Abacavir/dolutegravir/lamivudine	Medicare	Difficulty obtaining nicotine patch, not lozenge. Study staff asked hospital pharmacist to call independent pharmacist and insurer, at which time participant obtained patch.
11	Gum and patch	Emtricitabine/rilpivirine/tenofovir alafenamide	Medicaid, Medicare	Difficulty obtaining nicotine patch and gum. Both obtained same day after phone call by study staff to retail pharmacist.
12	Inhaler and patch	Abacavir/dolutegravir/lamivudine	Medicaid, Medicare	Difficulty obtaining nicotine patch and inhaler. Had OTC card. Ten days and multiple phone calls from hospital pharmacists to retail pharmacy and insurer resolved issue. Concern was proprietary brand of inhaler.
13	Lozenge and patch	Darunavir/cobicistat/dolutegravir/etravirine	Medicaid, Medicare	Difficulty with insurance coverage of patch from pharmacy, but not lozenge. Lozenge covered after phone call from research staff to pharmacist.
14	14mg patch, 4mg gum	Elvitegravir/ cobicistat/emtricitabine/ tenofovir	Medicare managed care	Insurance did not cover medication and participant was unable to pay for NRT. Participant was able to change pharmacy and receive free NRT through local pharmacy.
15	21 mg patch, 4 mg gum	Bictegravir/emtricitabine/ tenofovir alafenamide	Medicare managed care	Participant’s insurance did not cover NRT. Participant unable to change to local pharmacy and unable to pay out of pocket for NRT.
16	14 mg patch, 4 mg gum	Bictegravir/emtricitabine/ tenofovir alafenamide	Private HMO	NRT prescriptions initially not filled; filled after phone call from study team.
17	21 mg patch, inhaler	Bictegravir/emtricitabine/ tenofovir alafenamide	Medicaid managed care	Participant did not receive varenicline due to supply shortage of the starter pack at local pharmacy. Pharmacist wrote new prescription individual doses equivalent to starter pack doses.
18	14 mg patch, 2 mg gum	Bictegravir/emtricitabine/ tenofovir alafenamide	Medicaid managed care	Delivery of NRT was completed by pharmacy after first follow-up visit.
19	21 mg patch, inhaler	Elvitegravir/cobicistat/emtricitabine/ tenofovir	Medicare managed care	Insurance did not cover medication prescribed. Study pharmacist called retail pharmacy to provide medication at no additional cost. Pharmacy agreed.
20	21 mg patch, 4 mg gum	Bictegravir/emtricitabine/ tenofovir alafenamide	Private	Insurance did not cover medication prescribed. Study pharmacist called retail pharmacy to provide medication at no additional cost. Pharmacy agreed.

The most common reason for difficulty filling prescriptions was the apparent exclusion of coverage for nonprescription NRT by health plans including managed care plans in Medicaid and Medicare, and private plans. In addition, there appears to have been insufficient understanding among retail pharmacists of the scope of coverage for NRT, as phone calls from study personnel to pharmacists were usually able to resolve matters. For eight participants (40%), one or more phone calls from study staff to the retail pharmacy led to successful filling of NRT prescriptions. Of these 20 individuals, only one (5%) chose to buy nonprescription NRT out-of-pocket. Five participants (25%) were unable to fill their NRT at all; two of these individuals dropped out of the study. The remaining 15 participants were able to obtain NRT by alternate means, generally by phone calls from study personnel to the pharmacy. This resulted in delays up to 10 days in procuring NRT.

No participants reported difficulty filling prescriptions for varenicline or bupropion. All participants had ART covered by insurance, typically Medicaid and funding from the Ryan White program, without co-pays or deductibles. All filled their ART prescriptions uneventfully. Table 2 shows average wholesale costs of NRT, varenicline, and ART. Of note, ART typically cost about an order of magnitude more than MTUD.

Table 2.

Average wholesale price of HIV drugs and smoking cessation medications used by participants in current trial.

Condition Treated	Drug	Available over the counter?	Average wholesale price*	Covered by Medicaid or Medicaid/managed care plan?		Typical out-of pocket cost to study participants if not covered by insurance
				Connecticut	New York
Tobacco use disorder	Nicotine patch	Yes	$52.98–103.94** (28-day supply)	Yes	Yes	$24.00† (#28)
	Nicotine gum	Yes	$26.70–50.64** (100 pieces)	Yes	Yes	$16.00† (#100)
	Nicotine lozenge	Yes	$33.59 (72 pieces)	Yes	Yes	$20.00† (#100)
	Nicotine inhaler	No	$551.11 (168 cartridges)	Yes, with PA***	Yes	$483 (168 cartridges)
	Nicotine nasal spray	No	$578.66 (4 x 10mL)	Yes, with PA***	Yes	$506 (4 x 10ml bottles)
	Varenicline	No	$546.78 (30-day supply)	Yes	Yes	$14.00° (#60)
HIV	Bictegravir, tenofovir alafenamide, emtricitabine (Bictegravir/emtricita bine/tenofovir alafenamide)	No	$4,072/50 (30-day supply)	Yes	Yes	$0****
	Dolutegravir, abacavir, lamivudine (Abacavir/dolutegravir/lamivudine)	No	$3,818.26 (30-day supply)	Yes	Yes	$0****
	Elvitegravir, cobicistat, tenofovir alafenamide, emtricitabine (Elvitegravir/cobicistat/emtricitabine/tenofovir)	No	$4,072.50 (30-day supply)	Yes	Yes	$0****
	Dolutegravir + rilpivirine (Juluca)	No	$3,578.52 (30-day supply)	Yes	Yes	$0****

^*Source: McKesson Corporation via Yale-New Haven Hospital Pharmacy, 2021.

^**Range varies with use of brand or generic drug.

^***PA=prior authorization.

^****May require enrollment in state-based AIDS Drug Assistance Program.

^†Coupon-based pricing program (i.e. average GoodRx price) °Estimated 340B pricing

Connecticut Medicaid Preferred Drug List:

https://www.ctdssmap.com/CTPortal/Portals/0/StaticContent/Publications/CT_PDL_alpha.pdf

New York Medicaid Preferred Drug List: https://mmcdruginformation.nysdoh.suny.edu/search/

Discussion

We present 20 cases of PWH who were initially unable to obtain nonprescription NRT from a retail pharmacy, in contrast to ART. As a result, these individuals experienced gaps in MTUD and required interventions by study personnel.

Continued smoking may negatively affect the efficacy of ART, in part by decreased adherence, while increasing patients’ risk for the numerous diseases that are increasingly common causes of death for PWH worldwide.^6,7

The lack of real-world coverage for nonprescription NRT contravenes a goal of the Affordable Care Act: to make MTUD easily accessible. However, the PBMs that handle many public insurance managed care plans have carveouts for nonprescription medications, including NRT. These carveouts assume low-income individuals will purchase NRT out of pocket. A study from Germany found that only 20% of adults who smoke were willing to pay out-of-pocket for NRT, and of those willing to pay, many could not pay market price.⁸ Another study from the US found that Medicaid coverage of NRT increased utilization by 20%, but barriers such as cost sharing and prior authorization could depress utilization.^9,10 Indeed, in this case series only one of the 20 participants was willing to pay out-of-pocket for NRT.

An appropriate policy response could be to ensure that all payors PBMs include full coverage without cost sharing or prior authorization of all forms of NRT. Notably, in part prompted by our experiences, NRT was added to the Connecticut AIDS Drug Assistance Program (CADAP) in 2022.

Our study has limitations. We report results from only two states, both of which expanded access to Medicaid. New York’s 23 Medicaid managed care organizations (MCOs), second only to California’s 26,¹¹ with their various PBMs may create confusion among pharmacies looking to fill prescriptions. Last, given resource constraints, we did not examine participant-level characteristics that may have impacted access to MTUD.

Conclusion

Although nonprescription NRT is covered by insurance, in reality carveouts and insufficient understanding by pharmacies of benefit plans often leave individuals who smoke unable to secure effective treatment. This can result in paradoxes in which expensive specialty pharmaceuticals such as ART are covered, while much cheaper MTUD are not. We suggest all insurance plans pay for NRT irrespective of prescription status. This modest incremental expense will yield great gains in the quality and quantity of life for individuals who smoke.