Medicare Part D plans’ coverage and cost-sharing for acute rescue and preventive inhalers for chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the US,¹ affecting 15.7 million adults¹ and causing nearly 700,000 hospitalizations and 1.7 million emergency department visits in 2012.² Much of the burden of COPD falls heavily on Medicare, with 1 in 9 Medicare beneficiaries diagnosed with COPD³ and Medicare paying 51% of all US direct health care costs for COPD.⁴ Inhaled medications are key to relieving symptoms and improving health outcomes. However, up to 31% of Medicare beneficiaries using COPD inhalers have reported nonadherence due to cost.⁵ COPD inhaler costs increased dramatically in 2008, when a ban on chlorofluorocarbon propellants phased out generic inhalers, leaving only brand-name options.⁶ We examined coverage and cost-sharing for COPD inhalers in Medicare Part D plans, which covered 39 million beneficiaries in 2015.

Methods:

We analyzed the June 2015 Centers for Medicare and Medicaid Services Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files for all Part D plans nationwide, except special-needs plans which serve specific populations (e.g. long-term care) and may have specialized formularies. We focused on 21 inhalers in 7 treatment classes including short-acting rescue inhalers and longer-acting or preventive inhalers. For each inhaler, we averaged coverage and required out-of-pocket costs across all plans by counties and states, including Washington, D.C. For the most widely covered inhaler in each class, we projected yearly cost-sharing under a standard 2015 Part D benefit with a $320 deductible, and whether beneficiaries would reach the coverage gap where cost-sharing increases after total drug expenditures exceed a set threshold. Since COPD often causes costly hospitalizations², we explored whether Part D plans which provide both medical and drug benefits (Medicare Advantage Prescription Drug Plans [MA-PD]), offered better inhaler coverage than stand-alone Part D plans (Prescription Drug Plans [PDP]).

Results:

Our national analysis included 2,652 plans (1639 MA-PD, 1013 PDP). Between 93% to 100% of plans covered at least one inhaler in each class. Mean out-of-pocket costs ranged from $30 to $105 per inhaler, depending on the inhaler selected (Table 1). The projected annual out-of-pocket cost under a standard 2015 Part D benefit ranged from $494 to $1197 for the most widely covered inhaler in each class (Figure 1). For 5 of 7 classes, using a single inhaler each month would have produced annual out-of-pocket costs ≥$900 and caused beneficiaries to reach the coverage gap even without other medications. Patients with moderate to severe COPD requiring two or three inhalers per month (acute rescue and/or multiple preventive classes) would have had projected annual out-of-pocket expenses of $1,622 to $2,811, reaching the coverage gap by August or earlier.

Table 1.

Part D plans’ coverage and cost-sharing for inhalers for COPD^a

			Mean
			Plans cover inhaler					Out-of-pocket cost per inhaler					Total cost per inhalere
Class	Brand-name	Chemical name	All plans %	MA-PD plans %	PDP plans %	Difference (MA-PD vs. PDP) %		All plans $	MA-PD plans $	PDP plans $	Difference (MA-PD vs. PDP) $		All plans $
Acute Rescue Inhalersc
SABA	Proair	albuterold	92	94	92	2		30	40	28	12		52
SABA	Ventolin	albuterol	56	73	52	21		36	45	34	11		47
SABA	Xopenex	levalbuterol	32	33	30	3		38	61	33	28		59
SABA	Proventil	albuterol	17	50	11	39		50	77	31	46		66
SAMA	Atrovent	ipratropiumd	94	99	93	6		73	77	73	4		265
SABA/SAMA	Combivent	albuterol/ipratropiumd	93	99	92	7		63	63	63	0		284
Long-Acting and/or Preventive Inhalersc
LAMA	Spiriva	tiotropiumd	93	98	92	6		58	46	61	−15		320
LAMA	Tudorza	aclidinium	65	65	65	0		49	69	46	23		286
LABA	Serevent	salmeterold	94	99	93	6		50	51	49	2		261
LABA	Foradil	formoterol	83	92	81	11		39	47	38	9		225
LABA	Brovana	arformoterol	25	38	22	16		105	95	110	−15		333
LABA	Arcapta	indacterol	61	75	59	16		84	86	83	3		206
ICS	QVAR	beclomethasoned	90	97	89	8		39	44	38	6		191
ICS	Flovent	fluticasone	85	97	83	14		37	43	36	7		147
ICS	Asmanex	mometasone	81	93	71	22		42	52	40	12		159
ICS	Pulmicort	budesonide	40	46	39	7		64	58	66	−8		188
ICS	Alvesco	ciclesonide	25	50	20	30		90	85	93	−8		213
LABA/ICS	Dulera	formoterol/mometasoned	86	89	86	3		65	72	64	8		261
LABA/ICS	Breo Ellipta	vilanterol/fluticasone	85	89	84	5		60	57	61	−4		298
LABA/ICS	Symbicort	formoterol/budesonide	84	90	83	7		45	47	44	3		244
LABA/ICS	Advair	salmeterol/fluticasone	82	98	79	19		48	45	49	−4		244
Multiple Inhalers (Acute Rescue Inhaler and Long-Acting/Preventive Inhaler)
Two inhalers	Proair + Spiriva	albuterol + tiotriopium	--	--	---	---		88	86	89	−3		372
Three inhalers	Proair + Spiriva + Dulera	albuterol + tiotropium + formoterol / mometasone	--	--	---	---		148	158	153	5		617

^aAveraged across all plans in a county, then across all counties and states, including Washington D.C.

^bFewer than 1% of plans required Prior Authorizations except for arformoterol (24% of plans) and formoterol/mometasone (8% of plans).

^cSABA: short-acting beta agonists; SAMA: short-acting anticholinergic or muscarinic antagonists; LAMA: long-acting anticholinergic or muscarinic antagonists; LABA: long-acting beta agonists; ICS: inhaled corticosteroids.

^dMost widely covered inhaler in the class.

^eTotal cost = (cost paid by plan) + (out-of-pocket cost paid by beneficiary)

Figure 1. Projected Annual Out-of-Pocket Cost for COPD Inhalers Under a Standard 2015 Part D Benefit (Month Enter Coverage Gap).

Projected annual out-of-pocket costs to use 1 inhaler per month. Based on standard 2015 Part D plan with $320 deductible and coverage gap starting at $2960 in total drug costs. SABA: short-acting beta agonists; SAMA: short-acting anticholinergic or muscarinic antagonists; LAMA: long-acting anticholinergic or muscarinic antagonists; LABA: long-acting beta agonists; ICS: inhaled corticosteroid

n/a - projected cost of using 1 inhaler per month does not reach coverage gap threshold.

The vast majority (≥ 92%) of both MA-PD and PDP plans covered at least one inhaler per class, although MA-PD plans covered specific inhalers more frequently (Table 1); for 20 of 21 inhalers, the percentage of MA-PD plans providing coverage was 2% to 39% greater than PDP plans. However, MA-PD plans required higher out-of-pocket costs than PDP plans for 14 of 21 inhalers, with cost-sharing ranging from $2 to $46 higher per inhaler.

Discussion:

In our nationwide analysis of Medicare Part D plans, COPD inhalers were nearly universally covered but required high cost-sharing by beneficiaries. For many acute rescue and preventive inhalers, using a single inhaler each month had projected annual out-of-pocket costs ≥ $900 under a standard 2015 Part D plan even without other medications.

Our study limitations include projecting annual cost-sharing for each inhaler based on using one inhaler per month and no other prescriptions. We did not examine actual out-of-pocket costs, which reflect a beneficiary’s coverage phase when filling an inhaler prescription, which in turn is influenced by their non-COPD medication costs.

Our findings call into question whether Part D continues to adequately support beneficiaries in the face of rapidly rising drug prices. Part D plans and Medicare policy should reassess whether this high cost-sharing adversely affects inhaler adherence and health for beneficiaries with COPD.