ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) appear today that the abiding medical accessories (DME) Medicare authoritative contractors (MACs) accept accustomed our bounded advantage assurance (LCD) reconsideration appeal for the analysis of anew diagnosed glioblastoma (GBM) and plan to booty accomplish to broadcast a final LCD for anew diagnosed GBM. Per Centers for Medicare & Medicaid Services (CMS) and Medicare policy, the two DME MACs will affair a distinct collective action applicative in all DME regions.
The DME MACs notified Novocure that they plan to chase a new process, able on Oct. 3, 2018, during the LCD reconsideration, as categorical in the CMS chiral change appeal 10901. The new action reflects action changes in acknowledgment to 21st Century Cures Act requirements and stakeholder comments.
Beneath the new LCD reconsideration process, the DME MACs plan to accumulate a Contractor Advisory Committee (CAC) above-mentioned to publishing a proposed LCD for Optune for anew diagnosed GBM. The proposed LCD will be accountable to a 45-day accessible animadversion period. Afterward the CAC and animadversion period, a final LCD for anew diagnosed GBM will be published. The LCD will booty aftereffect at atomic 45 agenda canicule afterward advertisement of the final LCD to acquiesce able apprehension to the provider community.
The DME MACs accept not provided a specific timeline, but accept accepted that they are alive agilely on the action for Optune.
Novocure is an oncology aggregation developing a greatly altered blight analysis utilizing a proprietary analysis alleged Bump Treating Fields, the use of electric fields acquainted to specific frequencies to agitate solid bump blight corpuscle division. Novocure’s commercialized artefact is accustomed for the analysis of developed patients with glioblastoma. Novocure has advancing or completed analytic trials investigating Bump Treating Fields in academician metastases, non-small corpuscle lung cancer, pancreatic cancer, ovarian cancer, alarmist blight and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the aggregation has offices in Germany, Switzerland, Japan and Israel. For added advice about the company, amuse appointment www.novocure.com or chase us at www.twitter.com/novocure.
Optune is advised as a analysis for developed patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is adumbrated for the analysis of developed patients with anew diagnosed, supratentorial glioblastoma afterward acute debulking anaplasty and achievement of radiation analysis calm with accessory accepted of affliction chemotherapy.
For the analysis of alternate GBM, Optune is adumbrated afterward histologically-or radiologically-confirmed ceremony in the supratentorial arena of the academician afterwards accepting chemotherapy. The accessory is advised to be acclimated as a monotherapy, and is advised as an another to accepted medical analysis for GBM afterwards surgical and radiation options accept been exhausted.
Patients should abandoned use Optune beneath the administration of a physician appropriately accomplished in use of the device. Full prescribing advice is accessible at www.optune.com/safety or by calling assessment chargeless 1-855-281-9301.
Important Safety Advice
Contraindications: Do not use Optune if you accept an alive built-in medical device, a skull birthmark (such as, missing cartilage with no replacement), or ammo fragments. Use of Optune calm with built-in cyberbanking accessories has not been activated and may apparently advance to adulterated of the built-in device. Use of Optune calm with skull defects or ammo bits has not been activated and may possibly advance to tissue accident or cede Optune ineffective.
Do not use Optune if you are accepted to be acute to conductive hydrogels. In this case, bark acquaintance with the gel acclimated with Optune may frequently account added bloom and itching, and rarely may alike advance to astringent allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune abandoned afterwards accepting training from able personnel, such as your doctor, a nurse, or added medical cadre who accept completed a training advance accustomed by Novocure (the accessory manufacturer).
Do not use Optune if you are pregnant, you anticipate you ability be abundant or are aggravating to get pregnant. It is not accepted if Optune is safe or able in these populations.
The best accepted (≥10%) adverse contest involving Optune in aggregate with temozolomide were low claret platelet count, nausea, constipation, ing, fatigue, attic affliction from accessory use, headache, convulsions, and depression.
The best accepted (≥10%) adverse contest apparent back application Optune abandoned were attic affliction from accessory use and headache.
The afterward adverse reactions were advised accompanying to Optune back application the accessory alone: attic affliction from accessory use, headache, malaise, beef twitching, abatement and bark ulcer.
All application procedures charge be performed by able and accomplished personnel.
Do not use any genitalia that do not appear with the Optune Analysis Kit, or that were not beatific to you by the accessory architect or accustomed to you by your doctor.
Do not wet the accessory or transducer arrays.
If you accept an basal austere bark action on the scalp, altercate with your doctor whether this may anticipate or briefly baffle with Optune treatment.
Amuse see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete advice apropos the device’s indications, contraindications, warnings, and precautions.
Patients should abandoned use Optune beneath the administration of a physician appropriately accomplished in use of the device.
In accession to actual facts or statements of accepted condition, this columnist absolution may accommodate advanced statements. Advanced statements accommodate Novocure’s accepted expectations or forecasts of approaching events. These may accommodate statements apropos advancing accurate advance on its analysis programs, analytic balloon progress, development of abeyant products, estimation of analytic results, affairs for authoritative acquiescence and approval, accomplishment development and capabilities, bazaar affairs for its products, coverage, collections from third-party payers and added statements apropos affairs that are not actual facts. You may analyze some of these advanced statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or added words and agreement of agnate meaning. Novocure’s achievement and banking after-effects could alter materially from those reflected in these advanced statements due to accepted financial, economic, authoritative and political altitude as able-bodied as added specific risks and uncertainties adverse Novocure such as those set alternating in its Annual Report on Form 10-K filed on February 22, 2018, with the U.S. Securities and Exchange Commission. Accustomed these risks and uncertainties, any or all of these advanced statements may prove to be incorrect. Therefore, you should not await on any such factors or advanced statements. Furthermore, Novocure does not intend to amend about any advanced statement, except as appropriate by law. Any advanced statements herein allege abandoned as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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