Patient Assistance

When my doctor first suggested trying something stronger than the three DMARDs I was taking, one of my hesitations was the cost.  Biologics are expen$ive.  Fortunately, there are financial assistance programs to reduce patient’s out-of-pocket costs.

A year ago, after checking the details of the patient-assistance programs, I selected Enbrel (read here and here, then here and here).  Their website made it clear that given my situation, I wouldn’t have to pay more than $10 every four-weeks.  Humira, on the other hand, required me to release my family’s income information before giving any indication as to whether or not I qualified for their program (something I didn’t really want to do), and it wasn’t clear what the patient’s actual costs would be.

Recently I switched from Enbrel to Humira, and was happy to discover that they’ve changed their assistance criteria (or at least changed their presentation of it).  Maybe some people are still required to provide financial data, but I didn’t have to do that.  It turns out that a patient’s costs under Humira’s assistance program can be less than the cost of Enbrel.

 

The catch is that the Humira help desk was adamant that (despite what the literature says) this is for twelve fills, not twelve months.  I don’t know if that means the person didn’t know what he was talking about, or if it means patients pay the full amount for that final prescription fill of the year.*

If you’re on Humira, make sure your pharmacy knows that the patient assistance program picks up the co-pay on one of your other DMARDs, too.  I expected $5 each, and was thrilled to learn that it was $5 total.

Patient Assistance Programs for Biologic Medications:

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Monthly medications get twelve fills per year – unless your insurance only allows 30 days worth of meds per month, in which case twelve fills leaves you short five days of meds over the course of a year.

Twenty-eight day meds need thirteen fills per year.  28 days equal four weeks, and as any five-year-old card shark can tell you, 52/4=13 whether you’re talking about number of cards per suit, or number of four-week periods in a year’s worth of prescriptions medications.



FDA Grants Supplemental Approval for ACTEMRA® (tocilizumab)

I just received this press release, and thought I’d share it with you.  It’s nice to have more medication options in the fight against RA.

ACTEMRA now includes labeling for
the inhibition and slowing of structural joint damage,
improvement of physical function,
and achievement of major clinical response in rheumatoid arthritis

SOUTH SAN FRANCISCO, Calif. – January 5, 2011 – Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the United States (U.S.) Food and Drug Administration (FDA) has extended the ACTEMRA® (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). The supplemental approval comes one year after initial U.S. approval and supports the efficacy of ACTEMRA in treating RA.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to patients’ joints is a critical measure of the effectiveness of an RA treatment.

The new U.S. license extension was based on positive data from the Phase III LITHE trial which demonstrated that patients receiving either dose of ACTEMRA (4 mg/kg or 8 mg/kg) in combination with MTX had significantly less damage to their joints at one year, compared to patients in the control group. The outcome was determined by X-rays which measured the progression of bone erosions and narrowing of joint spaces over time.

“This FDA approval further supports the efficacy of Actemra and follows a similar approval in the EU,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals.”

The LITHE study also showed that patients who received either dose of ACTEMRA (4 mg/kg or 8 mg/kg) plus MTX showed significant improvement in physical function, compared with patients who received MTX plus placebo at week 52. More patients treated with ACTEMRA also achieved major clinical response, defined as achieving an ACR 70 response for a continuous 24-week period, compared to MTX plus placebo. No new or unexpected safety signals were identified with ACTEMRA, and safety was consistent with previous studies.

ACTEMRA was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat moderately to severe active RA in adult patients after an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. It can be used as monotherapy or in combination with MTX or other disease modifying anti-rheumatic drugs (DMARDS).

The treatment is also approved for use in the European Union and a growing number of other countries including Japan, Mexico, India, Brazil, Switzerland and Australia.

About the LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) Study
The LITHE study, a randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of tocilizumab plus MTX in preventing structural joint damage and improving physical function over two years. LITHE was an international study, including 15 countries and 1,196 patients with moderate to severe RA who had an inadequate response to MTX. In this randomized study, patients received either ACTEMRA (4 mg/kg or 8 mg/kg, one infusion every four weeks) in combination with MTX or MTX plus placebo. Results from the 12-month analysis showed that ACTEMRA 4 mg/kg slowed (less than 75 percent inhibition compared to the control group) and ACTEMRA 8 mg/kg inhibited (at least 75 percent inhibition compared to the control group) the progression of structural damage compared to MTX plus placebo. At 52 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8 mg/kg and 4 mg/kg plus MTX, and MTX plus placebo groups was: 0.25, 0.33 and 1.17 respectively. By week 104, the mean change from baseline was 0.34 and 0.47 for the 8 mg/kg plus MTX and 4 mg/kg plus MTX groups respectively.

The Genant-modified Sharp score focuses on 14 specific sites for evidence of bone erosion and 13 sites for narrowing of the joint space, both key measures of ongoing structural damage to the joints. A high score or an increase in the score over time represents a greater extent of damage. Improvement in physical function was measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). The HAQ-DI is a questionnaire that asks about physical functioning in the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and daily activities. Sixty-three percent and 60 percent of patients in the ACTEMRA 8 mg/kg plus MTX and ACTEMRA 4 mg/kg plus MTX groups respectively, achieved a clinically relevant improvement in HAQ-DI (change from baseline of ≥0.3 units) at week 52 compared to 53 percent in the MTX plus placebo group. Major clinical response, defined as achieving an ACR 70 response for a continuous 24 week period, was achieved in seven percent and four percent in the ACTEMRA 8 mg/kg plus MTX, ACTEMRA 4 mg/kg plus MTX groups, respectively, compared with one percent in the MTX plus placebo group.

About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic symptoms of RA. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States.

Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection in those already carrying the virus, nervous system problems, and serious allergic reactions.

Common side effects with ACTEMRA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.

Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.

For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit www.actemra.com or call 1-800-ACTEMRA (228-3672). ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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Ch-ch-ch-Changes

For nearly a year now, I’ve been injecting Enbrel weekly.  It was pretty scary in the beginning, but I like Enbrel.  I like how it makes me feel so much better.  I like how easy it is to use.  I like the once-a-week schedule so that it’s easy to remember and incorporate into a routine.  I like that it works.

My inflammatory markers look good.  Ten years ago, my response to the meds would be considered a success story.  Now, my rheumatologist tells me, the standards are higher.  She’s treating me, not my lab reports, and thinks I might do better on Humira.  I shouldn’t have new bursitis, I shouldn’t have enthesitis, my feet shouldn’t hurt all the time if these meds were doing their job 100%.  So, effective immediately, I’ve moved on to my second biologic.

I just got off the phone from trying to activate my new Humira card.  All the literature – yes, I actually read this stuff – says that the card is good for twelve months.

  • “This card is valid for 12 months from the date of first use, after which the patient has the option to reenroll (sic) in the program.”
  • “The program pays:  Months 1-12: Up to $500 each month”
  • “Easy to renew after 12 months”

After providing all my information, the voice on the other end of the phone concluded the conversation by saying that this card is good for twelve fills.

“No, you mean twelve months, right?  That’s what your literature says.” 

We went back and forth, her insisting that it’s only good for twelve fills, and me wondering why they won’t cover that last fill of the year when their written materials say that they’ll help out for a full twelve months.

A Humira prescription gets me a box of two injections to be given every-other-week, which should make one box last four weeks.  Divide fifty-two weeks of the year by four weeks per box, and it’s obvious that it takes thirteen fills to get through a year.  This is basic math that my eight-year-old understands; it should not be an impossible concept for an adult to grasp.

Some people will point out that I should be grateful that they’re picking up a portion of the cost.  And I am.  Really.  Extremely grateful.  I just happen to think it’s deceitful to tell people that the card is good for a year if it isn’t. (/rant)

I got my first Humira injection today.  I now have a headache – my first in over a year.  I hope that’s bad coincidental timing, and not a problem that I’ll have with the new med.  Since I’d heard that Humira stings much more than Enbrel, I was a bit concerned.  That turned out not to be true – at least for me.  It was about the same.  With any luck, that will continue.

And now, given that it’s only a week until Christmas, I should probably start my Christmas shopping.
Or baking.  Or packing for our trip.
Have a Merry Christmas!