Microsoft word - sample request for coverage of medically necessary therapy

YOUR NAME ADDRESS ADDRESS DATE PRIVATE INSURANCE OR MEDICAID ADDRESS ADDRESS Dear ________, I am respectfully requesting to appeal the decision of denial for my daughter’s medically necessary medications (Stiripentol, clobazam). It is my understanding that coverage for these medications were denied because a decision was made that the therapies were not proven to be effective. I am attaching several pieces of medical literature to the contrary. I am requesting that this information be reviewed and our request for coverage of stiripentol and clobazam be approved. My child, CHILD’S NAME, has been diagnosed with a malignant and catastrophic epileptic syndrome known as Severe Myoclonic Epilepsy of Infancy (SMEI) or Dravet syndrome. This rare genetic syndrome is due to a gene mutation that interferes with protein development in sodium channels in the brain. The faulty sodium channel causes febrile and eventually nonfebrile seizures (mostly life-threatening status epilepticus) in previously healthy infants. CHILD’S NAME has a confirmed genetic diagnosis that suggests she will present with the most severe spectrum of this disorder. In 1998 there were less than 500 reports of this syndrome in the world. It is now estimated that prevalence of this rare disorder ranges from 1:20,000 to 1:40,000 births. Dravet syndrome is characterized by a constellation of seizures presenting during the first year of life and including frequent life-threatening status epilepticus. All seizure types have been resistant to most antiepileptic drugs. CHILD’s NAME was born on DATE and her first seizure occurred on DATE. She had a generalized tonic clonic seizure that lasted TIME. GIVE DESCRIPTION IE: (Her first episode of life threatening status epilepticus occurred that night in the hospital at 1:45 am. This seizure was right sided then became generalized and lasted approximately one hour. She was given 10mg of valium a loading dose of Phenobarbital to stop the seizure and she was then transported via helicopter to the nearest children’s hospital where we ultimately spent most of the first 4 years of her life. Her status seizures have been to numerous to count. Many have lasted over an hour, 2, 3, and even 4 hours with the longest so far being 6 continuous hours. Many times she has been intubated and admitted to ICU for the seizures that have not been controlled by standard antiepileptic drugs. She has been transported via life-flight at least 8 times now with the most recent being this past July due to a seizure, she was admitted to ICU initially and spent four days in the hospital. ) CHILD’S NAME prognosis is poor. Seizures tend to persist and change and many occur in the middle of the night. Because of the poor control of the prolonged seizures and status epilepticus, most children become cognitively impaired, with as many as 50%
being severely mentally handicapped. The mortality rate is high due to status epilepticus
or sometimes sudden death.
The treatment for this malignant epilepsy has been disappointing. I have pursued very
aggressive seizure management for CHILD’S NAME and she is being seen by Dr.
____________ at NAME OF CLINIC (Mayo Clinic in Rochester, MN). Dr. ______ is an
epileptologist that specializes in epilepsy and has treated many children with Dravet
Syndrome. She would like to put CHILD’S NAME on stiripentol and clobazam for seizure
control since we have tried and failed all other drugs known to control seizures in SMEI.
Stiripentol is a novel anti-epileptic drug made by Biocodex in France for the treatment of
Dravet Syndrome. Stiripentol is the only drug in the world with an indication exclusively
for Dravet Syndrome (October 16, 2006 – European Medical Association). Stiripentol
and clobazam are designated as orphan drugs by the U.S. Food and Drug
Administration, the term “orphan drug” refers to a product that treats a rare disease
affecting fewer than 200,000 Americans. Clobazam has been used in Europe since the
1970s.The combination of stiripentol with clobazam, a novel benzodiazepine that is
made by Aventis and has been sold to Ovation seems to be the “magic cocktail” for
many children with Dravet Syndrome who have failed other treatment regimens.
Please approve our request for coverage of stiripentol and clobazam. Stiripentol
is PROVEN to benefit patients with Dravet syndrome (SMEI) and is the ONLY drug
indicated for this condition.
In a pharmacological report titled Stiripentol. A novel
antiepileptic drug
, it states in the final conclusion that “STP (stiripentol) is a novel
potential AED with a structure unrelated to any currently available or experimental
AED’s. It has proven its broad spectrum of antiepileptic activity in numerous models of
animal seizures, as well as in clinical trials. STP’s efficacy in partial and atypical absence
seizures has been confirmed. Moreover, no other AED has ever shown to possess
antiepileptic potency comparable to STP in SMEI.” This report further states that “STP
has good safety profile with relatively high therapeutic index. It is generally well
tolerated, even in epileptic children.” I am also attaching several medical journal articles
which include, Stiripentol (July 2005), which states, “although the studies in adult
patients were disappointing, the trials conducted in pediatric populations demonstrated a
specific efficacy of STP in a severe form of early childhood epilepsy, Dravet syndrome
(severe myoclonic epilepsy in infancy), when combined with valproate and clobazam.”
So far the AED’s that have proven to be ineffective in controlling CHILD’S NAME
seizures to date include, LIST MEDS IE: (phenobarbitol, tegretol, depakote, topamax,
clonazepam, trileptal, dilantan, keppra and more.) I feel that we have no option but to try
this combination of medications. Use of these medications will be closely supervised by
Dr. _______ at NAME of CLINIC (Mayo Clinic).
The proposed combination of drugs that Dr _______ at NAME of CLINIC (Mayo Clinic in
Rochester )has recommended for CHILD’S NAME could significantly improve her quality
of life, possibly save her life in addition and significantly reduce medical costs.
Fortunately, CHILD’S NAME has not suffered extensive brain damage to date
The aggressive management of her epilepsy will determine if she suffers further brain
damage and becomes more developmentally delayed, more severely mentally retarded,
or if she dies.
Thank you for your time and consideration of this request and please feel free to call me if you should need additional information Dr. ______, CHILD’S NAME epileptologist, are available for consultation should you need their expert opinion on the treatment of Dravet Syndrome. For more information on Dravet Syndrome, please visit the Dravet.org website at http://wwwdravet.org. Please contact me at (PHONE NUMBER AND/OR EMAIL) f you have any questions. I look forward to hearing from you soon. Sincerely, YOUR NAME

Source: http://dravet.org/sites/default/files/Sample%20Request%20for%20Coverage%20of%20Medically%20Necessary%20Therapy.pdf

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