Table 1.
Active Ingredients in Brand-Name Drugs with the Highest Medicare Part D Spending in 2017
| Active ingredient(s) | Brand-name product (dosage form; route of administration) [manufacturer] | Approval date of brand-name product | 2017 Average Medicare spending per beneficiary (on the brand-name product) | Active ingredient’s original product (dosage form; route of administration)* | Approval date of earliest brand-name product containing active ingredient(s) | Approval date of earliest generic or biosimilar product |
|---|---|---|---|---|---|---|
| Adalimumab | Humira Pen (injectable; subcutaneous) [Abbott] | 6/23/2006 | $38,888 | Humira (syringe; subcutaneous and vial; subcutaneous) | 12/31/2002 | 9/23/2016 |
| Apixaban | Eliquis (tablet; oral) [Bristol-Myers Squibb] | 12/28/2012 | $2692 | ✓ | 12/28/2012 | 6/28/2018 (tentative)¶ |
| Budesonide and formoterol | Symbicort# (aerosol, metered; inhalation) [AstraZeneca] | 7/21/2006 | $1516 | ✓† | 2/14/1994 (Budesonide) and 7/21/2006 (Formoterol) | -- |
| Cinacalcet | Sensipar (tablet; oral) [Amgen] | 3/8/2004 | $9302 | ✓ | 3/8/2004 | 3/8/2018 |
| Cyclosporine | Restasis# (emulsion; ophthalmic) [Allergan] | 12/23/2002 | $1856 | Sandimmune (injectable; injection, solution; oral and capsule; oral) | 11/14/1983 | -- |
| Dimethyl fumarate | Tecfidera (capsule, delayed release; oral) [Biogen] | 3/27/2013 | $60,047 | ✓ | 3/27/2013 | 8/17/2018 (tentative)¶ |
| Etanercept | Enbrel Sureclick (injectable; subcutaneous) [Immunex] | 6/14/2006‖ | $36,177 | Enbrel (syringe; subcutaneous and vial; subcutaneous) | 11/2/1998 | 8/30/2016 |
| Fluticasone and salmeterol | Advair Diskus# (powder; inhalation) [GlaxoSmithKline] | 8/24/2000 | $2091 | ✓‡ | 12/14/1990 (Fluticasone) and 2/4/1994 (Salmeterol) | -- |
| Glatiramer | Copaxone (injectable; subcutaneous) [Teva] | 12/20/1996 | $57,296 | ✓ | 12/20/1996 | 4/16/2015 |
| Ibrutinib | Imbruvica (capsule; oral and tablet; oral) [Pharmacyclis] | 11/13/2013 | $73,022 | ✓ | 11/13/2013 | -- |
| Insulin aspart | Novolog Flexpen (injectable; subcutaneous) [Novo Nordisk] | 1/19/2001 | $2804 | Novolog (injectable; subcutaneous) | 6/7/2000 | -- |
| Insulin detemir | Levemir Flextouch (injectable; subcutaneous) [Novo Nordisk] | 10/31/2013 | $2757 | Levemir (injectable; subcutaneous) | 6/16/2005 | -- |
| Insulin glargine | Lantus Solostar (injectable; injection) [Sanofi Aventis] | 4/27/2007 | $2366 | Lantus (injectable; injection) | 4/20/2000 | -- |
| Insulin glargine | Lantus (injectable; injection) [Sanofi Aventis] | 4/20/2000 | $2528 | ✓ | 4/20/2000 | -- |
| Insulin lispro | Humalog Kwikpen (injectable; injection) [Eli Lilly] | 9/6/2007 |
(U-100) $2628 (U-200) $3993 |
Humalog (injectable; injection) | 6/14/1996 | -- |
| Ledipasvir and Sofosbuvir | Harvoni (tablet; oral) [Gilead] | 10/10/2014 | $78,891 | ✓§ | 10/10/2014 (Ledipasvir) and 12/6/2013 (Sofosbuvir) | -- |
| Lenalidomide | Revlimid (capsule; oral) [Celgene] | 12/27/2005 | $88,437 | ✓ | 12/27/2005 | -- |
| Liraglutide | Victoza (solution; subcutaneous) [Novo Nordisk] | 1/25/2010 |
(2-pak) $2405 (3-pak) $4799 |
✓ | 1/25/2010 | -- |
| Lurasidone | Latuda (tablet; oral) [Sunovion] | 10/28/2010 | $8866 | ✓ | 10/28/2010 | 1/3/2019 |
| Palbociclib | Ibrance (capsule; oral) [Pfizer] | 2/3/2015 | $68,466 | ✓ | 2/3/2015 | -- |
| Pregabalin | Lyrica (capsule; oral and solution; oral) [Pfizer] | 12/30/2004 | $2872 | ✓ | 12/30/2004 | 9/26/2012 (tentative)¶ |
| Rivaroxaban | Xarelto (tablet; oral) [Janssen] | 7/1/2011 | $2741 | ✓ | 7/1/2011 | -- |
| Sevelamer | Renvela (tablet; oral and for suspension; oral) [Genzyme] | 10/19/2007 | $7156 | ✓ | 10/19/2007 | 6/13/2017 |
| Sitagliptin | Januvia (tablet; oral) [Merck] | 10/16/2006 | $3118 | ✓ | 10/16/2006 | 10/10/2012 (tentative)¶ |
| Tiotropium | Spiriva (powder; inhalation) [Boehringer Ingelheim] | 1/30/2004 | $2315 | ✓ | 1/30/2004 | -- |
*A checkmark (✓) indicates that the active ingredient(s) was first FDA-approved in the corresponding brand-name product in our cohort. For ingredients that were first approved in a different product, the name of the original product is listed
†Approved on 7/21/2006, Symbicort was the first drug containing the combination of both budesonide and formoterol. Budesonide was first approved in the product Rhinocort and formoterol was first approved in the product Symbicort
‡Approved on 8/24/2000, Advair Diskus was the first drug containing the combination of both fluticasone and salmeterol. Fluticasone was first approved in the product Cutivate and salmeterol was first approved in the product Serevent
§Approved on 10/10/2014, Harvoni was the first drug containing the combination of both ledipasvir and sofosbuvir. Ledipasvir was first approved in the product Harvoni and sofosbuvir was first approved in the product Sovaldi
‖The approval date of Enbrel Sureclick is publicly unavailable. The date of the earliest drug label containing information about Sureclick is listed
¶“Tentative approval” means that the product meets the requirements for FDA approval however is unable to receive final approval due to unexpired patents or exclusivity periods
#Approved indications of the product in our cohort and the original product differ for Symbicort/Rhinocort (asthma/rhinitis), Restasis/Sandimmune (dry eyes/transplant rejection), and Advair Diskus/Cutivate (chronic obstructive pulmonary disease/dermatoses)