TABLE C-3 Orphan Drugs with No, Very Low, or Low Plan Coverage (less than 50% coverage among all standalone PDPs) (7 drugs)

Generic Name

Trade Name

Stand-alone PDP Coverage (% plans that cover drug)

Route of Administration

Orphan Designation(s) (year of orphan approval)

Citric acid, glucono-deltalactone, and magnesium carbonate

Renacidin Irrigation

0a

Irrigation

Treatment of renal and bladder calculi of the apatite or struvite variety (1990)

Clofazimine

Lamprene

0

Oral

Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum (1986)

Glutamine

Nutrestore

0

Oral

For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface) (2004)

Zinc acetate

Galzin

0a

Oral

Treatment of Wilson’s disease (1997)

Lodoxamide tromethamine

Alomide Ophthalmic Solution

46

Ophthalmic

Treatment of vernal keratoconjunctivitis (1993)

Tinidazole

Tindamax

47

Oral

(1) Treatment of giardiasis; (2) treatment of amebiasis (2004)

Metronidazole (topical)

Metrogel

49

Topical

Treatment of acne rosacea (1988)

a These drugs had 0% coverage according to our analysis, which was limited to coverage of the drugs’ NDCs (listed in the FDB) in the January determined that Renacidin and Galzin are in fact covered by some PDPs as of June 2010. Galzin, which was a “high priority access problem drug” in the NORD analysis, is not on any national PDP formularies but appears on at least two nonnational formularies. Renacidin also appears on two national formularies and a few nonnational PDP formularies.



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