ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I just noticed something about Corti that is possibly giving them more traction in gaining scripts than many of us realize. According to United Healthcare, Acthar is only indicated for Infantile Spasms and Multiple Sclerosis by the FDA. Per labeling, it is suggested that Acthar may be used in the following conditions, however, it is not indicated for them by the FDA: Rheumatic Disorders, Collagen Diseases, Dermatologic Diseases, Allergic States, Ophthalmic Diseases, Respiratory Diseases, Edematous State.

Whereas the FDA indicates that Corti can be used for the following: • Rheumatic disorders, Collagen diseases, Dermatologic diseases, Allergic states, Ophthalmic diseases, Respiratory diseases, Edematous states, Nervous system.

The following coverage criteria shuts Acthar out of all conditions except Infantile Spasms, Multiple Sclerosis and Opsoclonus-Myoclonus Syndrome, where ANIP can still compete against Acthar. and allows for coverage of Corti for FDA approved indications.

2. Coverage Criteria:
A. Infantile Spasms (i.e., West Syndrome)
1. Initial Therapy
a. Acthar Gel and Purified Cortrophin Gel will be approved based on both of the
following criteria:
(1) Diagnosis of infantile spasms (West Syndrome)
-AND-
(2) Patient is less than 2 years of age
Authorization will be issued for 4 weeks by OptumRx.

2. Reauthorization
All requests for reauthorization will be denied by OptumRx. All requests for
continuation of therapy must be submitted through the appeals process to the
UnitedHealthcare Pharmacy appeals team for consideration.
B. Multiple Sclerosis
1. Initial Therapy
a. Acthar Gel and Purified Cortrophin Gel will be approved based on the following
criterion:
(1) Diagnosis of acute exacerbation of multiple sclerosis1
Authorization will be issued for 3 weeks by OptumRx.
2. Reauthorization
a. Acthar Gel and Purified Cortrophin Gel will be approved based on one the
following criteria:
(1) OptumRx can review a reauthorization request for a new (different) episode of
acute exacerbation of multiple sclerosis
-OR-
(2) All requests for reauthorization for treatment of the same exacerbation will be
denied by OptumRx. All requests for continuation of therapy for the same
exacerbation must be submitted through the appeals process to the
UnitedHealthcare Pharmacy appeals team for consideration.
Authorization will be issued for 3 weeks.
C. Opsoclonus-Myoclonus Syndrome (i.e., Kinsbourne Syndrome) (off-label)
1. Initial Authorization
a. Acthar Gel and Purified Cortrophin Gel will be approved based on the following
criteria:
(1) Diagnosis of opsoclonus-myoclonus syndrome
Authorization will be issued for 3 months by OptumRx.
2. Reauthorization
All requests for reauthorization will be denied by OptumRx. All requests for
continuation of therapy must be submitted through the appeals process to the
UnitedHealthcare Pharmacy appeals team for consideration.
D. Other Conditions:
1. Initial Authorization
a. Purified Cortrophin Gel will be approved based on one the following criteria:
(1) Rheumatic disorders: As adjunctive therapy for short-term administration (to
tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis.
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may
require low-dose maintenance therapy). Ankylosing spondylitis. Acute gouty
arthritis.
-OR-
(2) Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis
(polymyositis).
-OR-
(3) Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson
syndrome). Severe psoriasis.
-OR-
(4) Allergic states: Atopic dermatitis. Serum sickness.
-OR-
(5) Ophthalmic diseases: Severe acute and chronic allergic and inflammatory
processes involving the eye and its adnexa such as: Allergic conjunctivitis.
Keratitis. Iritis and iridocyclitis. Diffuse posterior uveitis and choroiditis. Optic
neuritis. Chorioretinitis. Anterior segment inflammation.
-OR-
(6) Respiratory diseases: Symptomatic sarcoidosis.
-OR-
(7) Edematous states: To induce a diuresis or a remission of proteinuria in the
nephrotic syndrome without uremia of the idiopathic type or that due to lupus
erythematosus.
Authorization will be issued for 12 months by OptumRx.
2. Reauthorization
a. Purified Cortrophin Gel will be approved based on the following criterion:
(1) Documentation of positive clinical response to Purified Cortrophin Gel therapy
Authorization will be issued for 12 months by OptumRx.

Looks like United Healthcare will cover FDA approved indications but not labelling label suggested conditions

UHC Coverage

When looking at Lalwani's statement in the last earnings CC it makes me wonder if he was referring to FDA approved indications for Acthar or including suggested indications.

"Now, something that I said at the last earnings call, which is when you look at a claims-based epidemiological analysis, right, that shows that less than 10% of patients who were steroid resistance and refractory across primary indications receive ACTH therapy. "

If primary indications relates to FDA approved indications the ANIP's target patient population just grew exponentially.

And, then there is Libigel.

GLTA